OncRef
Skip to newsletter content
|
NSCLCMarch 2026
0:00 / 3:52
Non-Small Cell Lung Cancer — Monthly Compass
Mar 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in non-small cell lung cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
Built for oncologists OncRef Curated Oncology Intelligence Layer
non-small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • The FDA granted accelerated approval on February 26, 2026 to Boehringer Ingelheim’s zongertinib (Hernexeos) for adults with unresectable or metastatic non‑squamous NSCLC harboring HER2 tyrosine kinase domain–activating mutations, with coverage noting applicability to treatment‑naïve patients under the expanded indication and that this was the second approval under the National Priority Voucher pilot.
  • Important Drug Publication Updates
    • Patient‑reported outcomes from PAPILLON show first‑line amivantamab plus chemotherapy significantly delays symptomatic progression in EGFR exon 20 insertion–mutated advanced NSCLC without compromising health‑related quality of life, reinforcing the regimen’s standard‑of‑care role.
    • A subgroup analysis of KEYNOTE‑671 in clinical stage II NSCLC reports perioperative pembrolizumab plus neoadjuvant chemotherapy significantly improved event‑free survival, overall survival, and pathological responses versus chemotherapy alone.
  • Key Clinical Development Updates
    • TRIANA’s TRI‑611, an oral molecular glue degrader for ALK‑positive NSCLC after two or more ALK tyrosine kinase inhibitors, received FDA Fast Track designation with first patient dosed in March 2026 in the phase 1/2 study NCT07491497 and plans for close FDA engagement under the program.
    • Nuvalent’s NDA for ROS1‑positive NSCLC was accepted with a PDUFA target action date of September 18, 2026, and investigators will discontinue the phase 3 TACTI‑004 frontline NSCLC trial of eftilagimod alfa plus pembrolizumab/chemotherapy following a futility recommendation.
  • Important Clinical Trial Publications
    • Stage 1 of the randomized phase 3 PRESERVE‑003 trial demonstrated that gotistobart monotherapy produced a clinically meaningful overall survival benefit versus docetaxel in metastatic squamous NSCLC resistant to PD‑1/PD‑L1 inhibitors and chemotherapy.
    • The phase III REZOR study found rezivertinib achieved statistically superior central nervous system efficacy, including prolonged CNS progression‑free survival, compared with gefitinib as first‑line therapy for EGFR‑mutated NSCLC with baseline brain metastases.
  • Key Conference Updates
    • ELCC 2026 signaled rapid convergence on PD‑(L)1×VEGF bispecifics, expansion of HER3/TROP2 antibody‑drug conjugates, precision inhibitors targeting resistance genotypes, and emerging perioperative and multimodal risk tools that sharpen patient selection in NSCLC.
  • Emerging Themes & Macro-Trends
    • Positive OS and CNS data signal potential elevation of PD‑(L)1×VEGF bispecifics over current IO+anti‑VEGF regimens, while HER3/TROP2 ADCs are poised to occupy post‑TKI niches with biomarker‑guided adoption.
    • Development strategies emphasize resistance‑focused combinations for KRAS/HER2/EGFR subsets and companion‑diagnostic and perioperative risk partnerships, with ongoing pivotal stages for selective CTLA‑4 and PD‑L1×VEGF‑A agents and planned HER3 ADC combination programs.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-03-01 and 2026-03-31 about non-small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • ACCC reported that the FDA granted accelerated approval to Boehringer Ingelheim’s zongertinib (Hernexeos) for adults with unresectable or metastatic non‑squamous NSCLC harboring HER2 tyrosine kinase domain–activating mutations, noting the agency’s February 26 decision and directing readers to the FDA announcement. The item highlights the expanded indication and links to sponsor resources for implementation. ¹ (accc-cancer.org) (read more)
  • AJMC summarized the FDA’s February 26 accelerated approval of zongertinib for HER2 TKD–mutant nonsquamous NSCLC, citing objective response and duration-of-response data that supported the decision. The March 6 roundup situates the lung cancer action among other February FDA developments. ² (ajmc.com) (read more)
  • CancerNetwork reported that investigators will discontinue the phase 3 TACTI‑004 frontline NSCLC study of eftilagimod alfa plus pembrolizumab/chemotherapy after a futility recommendation, and noted that an earlier FDA Type C meeting (July 2024) had provided positive feedback on the trial’s design. The article details plans to wind down the study in accordance with regulatory considerations. ³ (cancernetwork.com) (read more)
  • Nuvalent issued a March 17 update on AACR 2026 presentations for zidesamtinib and reiterated that the FDA has accepted its NDA for ROS1‑positive NSCLC with a PDUFA target action date of September 18, 2026. The company also notes breakthrough therapy and orphan designations associated with the program. ⁴ (prnewswire.com) (read more)
  • ILCN/WCLC covered that zongertinib received FDA accelerated approval for HER2‑mutant NSCLC and framed the action as the second approval under the Commissioner’s National Priority Voucher pilot, describing the expedited review mechanics and prior accelerated approval history. The piece underscores applicability to treatment‑naïve patients under the expanded indication. ⁵ (ilcn.org) (read more)
  • TRIANA Biomedicines announced the FDA granted Fast Track designation for TRI‑611, an oral molecular glue degrader for ALK‑positive NSCLC after two or more ALK TKI therapies; the company also noted the first patient was dosed earlier in March in its phase 1/2 trial (NCT07491497). TRIANA said it plans to work closely with FDA under the Fast Track program. ⁶ (biospace.com) (read more)
  • CancerNetwork reported the FDA Fast Track designation for TRI‑611 in ALK‑positive NSCLC, referencing TRIANA’s press release and ongoing phase 1/2 development. The article reiterates that the designation targets patients progressing after at least two ALK TKIs. ⁷ (cancernetwork.com) (read more)
  • Targeted Oncology detailed the FDA’s Fast Track designation for TRI‑611 in refractory ALK‑positive NSCLC, emphasizing the pathway’s benefits (more frequent FDA interactions and potential rolling review) and outlining the phase 1/2 program. The report situates the degrader’s mechanism and planned expansion cohorts within current resistance challenges. ⁸ (targetedonc.com) (read more)
  • Simply Wall St highlighted Summit Therapeutics’ ivonescimab program in EGFR‑mutated NSCLC, noting presentation of phase 3 data at ELCC 2026 and that the BLA has been submitted with a PDUFA decision expected in November 2026. The coverage links clinical updates to the defined FDA review timeline. ⁹ (simplywall.st) (read more)
  • Lantern Pharma’s business update disclosed that in March 2026 the company submitted a Type C meeting package to FDA for the phase 2 HARMONIC NSCLC study (LP‑300) and that the meeting is scheduled for mid‑May 2026 to discuss protocol amendments. Proposed changes include focusing enrollment on EGFR L858R, extending LP‑300 cycles, and converting to a Simon two‑stage single‑arm design. ¹⁰ (ir.lanternpharma.com) (read more)
Conference
Major Conference Updates
Conference Information
  • European Lung Cancer Congress (ELCC) 2026; Copenhagen, Denmark; March 25–28, 2026. (read more)
  • Overall, ELCC 2026 signaled rapid convergence on bispecific IO×angiogenesis strategies, ADC expansion (HER3/TROP2), and precision inhibitors, with emerging multimodal and perioperative risk tools sharpening patient selection in NSCLC. (read more)
  • Theme 1: Next-gen immunomodulators (PD‑(L)1×VEGF and selective CTLA‑4)
    • Significance: Dual checkpoint/anti‑angiogenic agents aim to consolidate efficacy seen with IO+bevacizumab-type regimens while simplifying delivery; selective CTLA‑4 could rescue benefit post‑chemo‑IO. (read more)
    • Mechanism insights / clinical impact: Pumitamig (BNT327/BMS986545; PD‑L1×VEGF‑A) showed 1L NSCLC activity irrespective of PD‑L1 and signals in EGFR‑mutant disease with chemotherapy; gotistobart (BNT316/ONC‑392; CTLA‑4, TME‑selective Treg depletion) yielded a 54% death‑risk reduction vs chemotherapy in stage 1 of PRESERVE‑003 (2L+ squamous NSCLC); ivonescimab (SMT112/AK112; PD‑1×VEGF) improved intracranial PFS in HARMONi without new safety signals. (read more)
    • Patient populations affected: 1L advanced NSCLC (all histologies), EGFR‑mutant post‑TKI, 2L+ squamous NSCLC; including patients with/without baseline brain metastases; global programs with China‑generated datasets and ongoing pivotal trials (ROSETTA Lung‑01/02). (read more)
  • Theme 2: ADC momentum centered on HER3 and TROP2
    • Significance: ADCs are moving into post‑standard settings with potential biomarker‑guided adoption; HER3 emerges as a leading target in NSCLC. (read more)
    • Mechanism insights / clinical impact: First Phase 2 NSCLC data for BNT326/YL202 (HER3 ADC) reported antitumor activity and favorable safety; ELCC hosted a dedicated symposium emphasizing latest TROP2‑directed ADC data and biomarker analysis—foreshadowing refinement of patient selection. (read more)
    • Patient populations affected: Advanced/metastatic NSCLC after progression on standard therapies; biomarker‑enriched cohorts under exploration. (read more)
  • Theme 3: Precision inhibition and resistance‑overcoming combinations
    • Significance: Broadening the actionable landscape (KRAS G12D/G12C, EGFR ex20ins, HER2) and tackling IO resistance via DDR+IO may reset sequencing. (read more)
    • Mechanism insights / clinical impact: Setidegrasib (KRAS G12D), MK‑1084+pembrolizumab (KRAS G12C; KANDLELIT‑001), zongertinib (HER2), and becotarug (JMT101)+osimertinib (EGFR ex20ins; BECOME) featured; LATIFY (ceralasertib+durvalumab) targets ATR‑mediated repair to re‑sensitize IO‑refractory NSCLC. (read more)
    • Patient populations affected: Molecularly defined advanced NSCLC subsets across 1L and pretreated settings, including IO‑resistant disease. (read more)
  • Theme 4: Multimodal and perioperative risk‑adapted strategies
    • Significance: Data refine who benefits from local consolidative therapy (LCT) after targeted induction and introduce blood‑based epigenetic risk tools for surgical candidates. (read more)
    • Mechanism insights / clinical impact: NorthStar secondary analysis identified subgroups (e.g., nodal clearance, no pleural effusion) with pronounced PFS gains from LCT alongside osimertinib; preoperative H3K27Me3‑nucleosome levels (Nu.Q) stratified recurrence risk and may flag micro‑metastatic disease. (read more)
    • Patient populations affected: Metastatic EGFR‑mutant NSCLC eligible for LCT; resectable NSCLC requiring adjuvant‑intensity tailoring. (read more)
  • Significance
    • Expected clinical or translational readouts: Ongoing pivotal stages for gotistobart (PRESERVE‑003) and pumitamig (ROSETTA Lung‑01/02); HER3 ADC combinations (BNT326/YL202+pumitamig). (read more)
    • Regulatory or policy implications: Ivonescimab BLA accepted (PDUFA November 14, 2026), positioning PD‑1×VEGF for near‑term US review. (read more)
    • Potential shifts in standard of care: Positive OS/CNS data could elevate PD‑(L)1×VEGF bispecifics over current IO+anti‑VEGF; ADCs may claim post‑TKI niches; LCT applied more selectively; perioperative nucleosome assays could steer adjuvant decisions. (read more)
    • Strategic implications: Prioritize bispecific IO‑angiogenesis portfolios, invest in HER3/TROP2 ADC biomarker strategies, and design resistance‑focused combinations for KRAS/HER2/EGFR subsets; build companion‑diagnostic and perioperative risk partnerships. (read more)
Publications Related to Approved Drugs
Phase 3
amivantamab
Patient-reported outcomes and time to symptomatic progression from PAPILLON: amivantamab plus chemotherapy vs chemotherapy as first-line treatment of EGFR exon 20 insertion-mutated advanced NSCLC. First-line treatment with amivantamab plus chemotherapy significantly delays symptomatic progression in advanced NSCLC with EGFR exon 20 insertions without compromising health-related quality of life. This highlights the regimen's dual benefit of extending progression-free survival while maintaining patient well-being, solidifying its role as a standard-of-care option. ()
Phase 3
amivantamab
Amivantamab plus chemotherapy versus chemotherapy for first-line treatment of participants with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer: PAPILLON Asia subgroup analysis. In the Asian sub-cohort of the PAPILLON trial, amivantamab combined with chemotherapy demonstrated superior progression-free survival and objective response rates compared to chemotherapy alone for EGFR exon 20 insertion-mutated advanced NSCLC. These findings confirm the robust efficacy and tolerability of this combination in Asian populations, supporting its use as a first-line therapeutic strategy. ()
Phase 3
atezolizumab, atezolizumab and hyaluronidase-tqjs
IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer. Adjuvant atezolizumab demonstrated numerically improved disease-free survival and overall survival versus best supportive care in Japanese patients with resected stage IB-IIIA NSCLC, maintaining a tolerable safety profile consistent with the global population. These 5-year outcomes reinforce the long-term clinical benefit and strategic value of atezolizumab consolidation in early-stage, resectable NSCLC. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 1
Datopotamab Deruxtecan Plus Pembrolizumab With or Without Platinum-Based Chemotherapy for Advanced or Metastatic NSCLC: The Phase Ib TROPION-Lung02 Trial. Dato-DXd plus pembrolizumab, with or without platinum-based chemotherapy, demonstrated appreciable safety and durable antitumor activity across PD-L1 expression levels in patients with advanced or metastatic NSCLC. Exploratory biomarker analyses suggest trends toward improved survival outcomes in TROP2 biomarker-positive patients, highlighting a promising combination strategy. ()
PHASE1, PHASE2
Pan-tumor activity of olomorasib, a next-generation KRAS G12C inhibitor in KRAS G12C-mutant advanced solid tumors: a first-in-human study. Olomorasib, a next-generation KRAS G12C inhibitor, was well tolerated and demonstrated promising antitumor activity, including intracranial responses, in patients with KRAS G12C-mutant advanced solid tumors. These findings support its potential to overcome limitations of earlier agents and justify further investigation in combination therapies. ()
Phase 3
Perioperative Nivolumab in Resectable Non-Small Cell Lung Cancer: A Subanalysis of Japanese Patients From CheckMate 77T. Perioperative nivolumab significantly improved event-free survival, pathological complete response, and major pathological response compared to placebo in Japanese patients with resectable NSCLC. These results are consistent with the global population, supporting the use of this perioperative regimen with a manageable safety profile. ()
Phase 3
A Subgroup Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-Small-Cell Lung Cancer from the Randomized KEYNOTE-671 Study. Perioperative pembrolizumab plus neoadjuvant chemotherapy significantly improved event-free survival, overall survival, and pathological responses versus chemotherapy alone in patients with clinical stage II NSCLC. These findings support the integration of perioperative pembrolizumab into the treatment paradigm for early-stage, resectable disease. ()
Phase 3
Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Gotistobart, a novel anti-CTLA-4 antibody, demonstrated a clinically meaningful overall survival benefit compared to docetaxel in patients with metastatic squamous NSCLC resistant to PD-1/PD-L1 inhibitors and chemotherapy. This suggests gotistobart monotherapy could be a valuable therapeutic option for this poor-prognosis population. ()
Phase 3
Rezivertinib in EGFR-Mutated Non-Small Cell Lung Cancer Patients with Central Nervous System Metastasis: Central Nervous System Efficacy from the Phase III REZOR Study. Rezivertinib demonstrated statistically significant superior central nervous system (CNS) efficacy, including prolonged CNS progression-free survival, compared to gefitinib as a first-line treatment for advanced EGFR-mutated NSCLC patients with baseline CNS metastases. This highlights rezivertinib as a highly effective targeted therapy for managing intracranial disease. ()
Phase 3
Cost-effectiveness analysis of rezivertinib and gefitinib in patients with EGFR-mutated advanced non-small cell lung cancer. A cost-effectiveness analysis based on the REZOR trial indicates that rezivertinib provides superior clinical outcomes and is highly cost-effective compared to gefitinib for the first-line treatment of EGFR-mutated advanced NSCLC in China. This economic evaluation supports the broader clinical adoption of rezivertinib in this setting. ()
Phase 1
Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial. This phase Ia trial protocol outlines the investigation of intrathecal pemetrexed combined with bevacizumab to address drug resistance and improve outcomes in NSCLC patients with leptomeningeal metastases. The study aims to establish the safety and preliminary efficacy of this novel intrathecal combination strategy. ()
PHASE1, PHASE2
Distinct Tumor-Immune Ecologies in Patients with Lung Cancer Predict Progression and Define a Clinical Biomarker of Therapy Response. Multiplexed imaging and spatial analysis of NSCLC tissues revealed distinct tumor-immune ecologies that predict disease progression and response to immunotherapy combined with a histone deacetylase inhibitor. These learned spatial ecologies offer a potential companion biomarker to PD-L1, enhancing the precision of immunotherapy patient selection. ()
Phase 2
Decoding B Cell Signatures of Complete Pathological Response to Perioperative Chemoimmunotherapy in Non-Small Cell Lung Cancer. Multiomic profiling revealed that a complete pathological response to perioperative chemoimmunotherapy in NSCLC is associated with a pre-existing, clonal, and mature B cell response that is further reinvigorated during treatment. These B cell receptor metrics and tertiary lymphoid structure characteristics emerge as promising predictive biomarkers for therapeutic efficacy. ()
Phase 2
First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study. The combination of sacituzumab govitecan and pembrolizumab demonstrated promising first-line clinical activity in metastatic NSCLC, particularly in patients with a PD-L1 tumor proportion score of 50% or greater. The safety profile was manageable, supporting further evaluation of this antibody-drug conjugate and immunotherapy combination. ()
Phase 2
Genomic Profiling of Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Post-Progression on First-Line Osimertinib: Phase II ORCHARD Study. Comprehensive genomic profiling of EGFR-mutated NSCLC post-progression on first-line osimertinib revealed highly heterogeneous resistance mechanisms, including frequent TP53 and MDM2/4 alterations, and differential co-occurring mutations based on the primary EGFR alteration. This highlights the necessity of broad-acting combination strategies to overcome complex resistance landscapes. ()
Phase 2
Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD. The combination of osimertinib and datopotamab deruxtecan demonstrated meaningful clinical benefit and durable responses in patients with EGFR-mutated advanced NSCLC who progressed on first-line osimertinib. A starting dose of 6 mg/kg for datopotamab deruxtecan is recommended, balancing robust efficacy with a manageable safety profile through proactive monitoring. ()
Phase 1
Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. The Beamion PANTUMOR-1 trial is evaluating zongertinib, a novel, highly selective HER2 tyrosine kinase inhibitor, in patients with previously treated HER2-altered solid tumors, including non-squamous lung cancer. This study aims to confirm the encouraging preliminary activity and favorable safety profile of zongertinib by sparing wild-type EGFR-related toxicities. ()
Phase 2
How does pulmonary function impact QoL in patients with locally advanced NSCLC treated with chemoradiotherapy and durvalumab? In patients with stage III NSCLC treated with chemoradiotherapy and durvalumab, health-related quality of life remained stable throughout treatment, although patients with concurrent COPD reported modestly lower global health scores and higher dyspnea. These findings suggest that while baseline lung impairment affects overall well-being, the treatment regimen itself does not significantly deteriorate quality of life. ()
Phase 2
Andamertinib in Advanced NSCLC With EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results From the Phase 2 KANNON Study. Andamertinib, a selective tyrosine kinase inhibitor, demonstrated a robust confirmed objective response rate of 42.7% and a manageable safety profile in previously treated patients with advanced NSCLC harboring EGFR exon 20 insertions. Notably, it also showed strong systemic efficacy in patients with brain metastases, positioning it as a promising targeted therapy for this challenging mutation. ()
Phase 1
Refractory microsatellite-stable metastatic colorectal cancer: a comparison between botensilimab + balstilimab and current standard of care. A comparative analysis suggests that the immunotherapy combination of botensilimab and balstilimab offers superior overall and progression-free survival compared to current standard-of-care options for heavily pre-treated, microsatellite-stable metastatic colorectal cancer. While presenting a distinct toxicity profile, this combination represents a potentially transformative option pending randomized trial confirmation. ()
Phase 1
Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial. The combination of linavonkibart, a novel anti-latent TGFβ1 antibody, and pembrolizumab demonstrated a manageable safety profile and promising objective response rates in patients with advanced solid tumors resistant to prior anti-PD-1 therapy. These results provide proof-of-mechanism for targeting TGFβ1 to overcome immune checkpoint inhibitor resistance. ()
Phase 2
Phase 2 Study of Amivantamab Plus Lazertinib in Previously Treated Patients With EGFR-Mutant Lung Cancers With Brain and Leptomeningeal Metastases. The combination of amivantamab and lazertinib demonstrated significant antitumor activity and durable responses in patients with EGFR-mutant lung cancer who developed new or progressing brain or leptomeningeal metastases. This highlights the regimen's potential to effectively manage challenging central nervous system disease post-prior targeted therapy. ()
Phase 2
Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials. Durvalumab-containing combination therapies showed promising efficacy and disease control in patients with recurrent or metastatic pulmonary sarcomatoid carcinoma, regardless of PD-L1 expression levels. Additionally, a lower circulating CD4+/CD8+ T cell ratio was identified as a potential biomarker associated with favorable disease control. ()
PHASE1, PHASE2
Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer. Long-term follow-up from the ARROW study confirms that pralsetinib delivers robust, durable objective responses and prolonged overall survival in both treatment-naïve and previously treated patients with advanced RET fusion-positive NSCLC. The safety profile remained manageable, reinforcing pralsetinib as a highly effective targeted standard of care. ()
Phase 2
Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials. Durvalumab-containing combination therapies showed promising efficacy and disease control in patients with recurrent or metastatic pulmonary sarcomatoid carcinoma, regardless of PD-L1 expression levels. Additionally, a lower circulating CD4+/CD8+ T cell ratio was identified as a potential biomarker associated with favorable disease control. ()
Phase 2
Decoding B Cell Signatures of Complete Pathological Response to Perioperative Chemoimmunotherapy in Non-Small Cell Lung Cancer. Multiomic profiling revealed that a complete pathological response to perioperative chemoimmunotherapy in NSCLC is associated with a pre-existing, clonal, and mature B cell response that is further reinvigorated during treatment. These B cell receptor metrics and tertiary lymphoid structure characteristics emerge as promising predictive biomarkers for therapeutic efficacy. ()
Phase 3
Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with First-Line Cemiplimab-Based Therapy. In patients with advanced NSCLC receiving first-line cemiplimab-based therapy, improvements in post-baseline patient-reported outcomes, specifically global health status and quality of life, were significantly associated with a reduced risk of death. These findings underscore the prognostic value of patient-reported metrics and support their integration into clinical trial endpoint selection. ()
Phase 3
Review of patient-reported outcomes in EMPOWER-Lung 1 in patients with advanced non-small cell lung cancer treated with cemiplimab versus chemotherapy. First-line cemiplimab monotherapy significantly improved global health status and quality of life compared to chemotherapy in patients with advanced NSCLC and high PD-L1 expression. This benefit was consistent across multiple patient subgroups, further supporting the comprehensive clinical value of cemiplimab in this setting. ()
Phase 2
Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. The majority of NSCLC patients strongly preferred subcutaneous administration of atezolizumab over intravenous delivery, independent of baseline characteristics or injection duration. This preference was particularly pronounced in older patients, highlighting the potential for subcutaneous formulations to enhance patient experience and treatment convenience. ()
Phase 2
Efficacy of Neratinib-Based Therapy in ERBB2-Mutant Lung Adenocarcinomas: Findings From 2 International Phase 2 Studies. Single-agent neratinib demonstrated limited clinical activity in patients with ERBB2-mutated lung adenocarcinomas. Furthermore, combining neratinib with temsirolimus or trastuzumab did not substantially improve overall outcomes, yielding durable responses in only a very limited subset of patients. ()
Phase 1
Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients With Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies. Zanidatamab, a dual HER2-targeted bispecific antibody, demonstrated a promising confirmed objective response rate of 44% and durable progression-free survival in patients with previously treated HER2-positive salivary gland cancer. These early-phase results support the clinical benefit and manageable safety profile of zanidatamab in this rare, difficult-to-treat malignancy. ()
Phase 2
ELIOS: A Multicenter, Molecular Profiling Study of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer Treated with First-Line Osimertinib. Molecular profiling of EGFR-mutant NSCLC post-progression on first-line osimertinib identified diverse acquired resistance mechanisms, including MET amplification and EGFR C797S mutations, alongside consistently high TROP2 expression. The complementary use of tissue and plasma next-generation sequencing underscores the need for broad-acting therapeutic strategies to address heterogeneous resistance. ()
Phase 3
First-Line Tislelizumab Plus Chemotherapy for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer: 4-Year Long-Term Follow-Up from RATIONALE-307. Four-year follow-up data confirm that first-line tislelizumab combined with chemotherapy provides durable and clinically meaningful overall and progression-free survival benefits compared to chemotherapy alone in advanced squamous NSCLC. The combination maintained a well-tolerated safety profile, solidifying its role as a standard-of-care option for this patient population. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in non-small cell lung cancer updated from 2026-03-01 to 2026-03-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1-----1
Not Yet Recruiting351923234
Recruiting503752534-178
Available-------
Approved for Marketing-------
Active, Not Recruiting2418261292100
Completed--4-1-5
Total78601018674318
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Zimberelimab, Oxaliplatin, Fluorouracil, Leucovorin, AB598 NCT05891171 ACTIVE_NOT_RECRUITING A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies 2026-03
RAD301 ([68Ga]-RAD301) NCT05799274 RECRUITING Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors 2026-03
sasanlimab, PF-08046037 NCT06974734 ACTIVE_NOT_RECRUITING AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES 2026-04-30
Cofetuzumab Pelidotin NCT04189614 ACTIVE_NOT_RECRUITING A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer 2026-05
PF-08046049 NCT05571839 ACTIVE_NOT_RECRUITING A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors 2026-06-06
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Durvalumab Injection [Imfinzi] NCT04351256 COMPLETED Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy - Employing Optimized (Hypofractionated) Radiotherapy to Foster Durvalumab Efficacy 2026-01-21
pembrolizumab, brentuximab vedotin NCT04609566 COMPLETED A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies 2026-02-03
DS-1062a NCT04484142 COMPLETED Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05) 2026-02-04
Immune checkpoint inhibitor NCT03313804 COMPLETED Priming Immunotherapy in Advanced Disease With Radiation 2026-02-16
Trametinib, Docetaxel NCT02642042 ACTIVE_NOT_RECRUITING A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies 2026-03-19
Tyrosine kinase inhibitor, Brigatinib NCT04318938 ACTIVE_NOT_RECRUITING Advancing Brigatinib Properties in Anaplastic Lymphoma Kinase Positive Non-small Cell Lung Cancer (ALK+ NSCLC) Patients 2026-04-30
Entrectinib NCT02568267 ACTIVE_NOT_RECRUITING An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements 2026-05-14
Cemiplimab, Ipilimumab NCT05401786 ACTIVE_NOT_RECRUITING Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC 2026-06
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: Pembrolizumab NCT02504372 COMPLETED A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS) 2026-01-21
AMG 510, Docetaxel NCT04303780 ACTIVE_NOT_RECRUITING A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C 2026-05-29
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
NOTICE: This communication may contain confidential or proprietary information of Oncology Reference, Inc. Data is compiled from publicly available and third-party sources and integrated with proprietary Oncology Reference database mappings, developed and maintained by PhD scientists and advanced AI systems, for organization and analysis. While reasonable efforts are made to ensure accuracy and timeliness, Oncology Reference, Inc. makes no representation or warranty, express or implied, regarding accuracy, completeness, or fitness for a particular purpose. Information may contain errors, omissions, or be subject to change without notice. This material is for informational purposes only and is not medical advice, regulatory guidance, investment advice, or a substitute for professional judgment. Users must independently verify all information.

Oncology Reference, Inc. and its affiliates disclaim all liability for any loss or damage arising from use of or reliance on this information. By using this information, you agree that disputes will be governed by Delaware law and resolved by binding arbitration in Delaware.
California residents waive California Civil Code § 1542. All trademarks are the property of their respective owners.
© 2025 Oncology Reference, Inc. All rights reserved.

CONFIDENTIALITY NOTICE: If you are not the intended recipient, please notify the sender, delete this message, and refrain from using or disclosing its contents.