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NSCLCSeptember 2026
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Non-Small Cell Lung Cancer — Monthly Compass
Sep 01–30, 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.
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non-small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • On September 9, 2026, FDA granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for adult patients with locally advanced or metastatic non‑squamous NSCLC harboring HER2 (ERBB2) TKD activating mutations, expanding the indication to treatment‑naïve patients under Project Orbis with the UK MHRA and following Priority Review plus Breakthrough Therapy and Orphan Drug designations.
    • EVOKE‑03/KEYNOTE‑D46 demonstrated that sacituzumab govitecan plus pembrolizumab failed to improve PFS or OS over pembrolizumab, reinforcing single‑agent pembrolizumab as standard of care for first‑line PD‑L1 TPS ≥50% metastatic NSCLC.
  • Key Clinical Development Updates
    • Fast Track momentum included FDA designations for OncoC4’s cesalatamig (AI‑081; PD‑1/VEGF bispecific) after PD‑(L)1 and platinum therapy as it advances toward registrational phase 3, BlossomHill’s BH‑30643 (macrocyclic OMNI‑EGFR) for EGFR C797S‑positive NSCLC with a Q4 2026 End‑of‑Phase 1 meeting and a pivotal phase 2 planned for Q1 2027, and BeyondSpring’s plinabulin plus docetaxel in post‑ICI non‑squamous NSCLC alongside a strategic transaction propelling the global phase 3 DUBLIN‑4 trial toward its planned interim analysis and a confirmatory path expected to support a future NDA.
    • FDA approved a supplemental NDA for Nuvation Bio’s IBTROZI (taletrectinib) to update U.S. labeling with longer duration‑of‑response data in TKI‑naïve advanced ROS1‑positive NSCLC, fulfilling a post‑marketing commitment tied to the original approval.
  • Important Clinical Trial Publications
    • Final PAPILLON results in EGFR exon 20 insertion‑positive NSCLC confirmed durable clinical benefit with the longest median overall survival reported to date for this population, corroborating efficacy that led to amivantamab’s March 2024 FDA approval.
  • Key Conference Updates
    • WCLC 2026 solidified precision first‑lines as trastuzumab deruxtecan improved PFS versus chemo‑IO in first‑line HER2‑mutant NSCLC (14.3 vs 8.3 months; HR 0.63), zipalertinib plus chemotherapy extended PFS in first‑line EGFR exon 20 insertion disease (14.5 vs 8.5 months; HR 0.50), zidesamtinib achieved 94% ORR with 100% intracranial ORR in TKI‑naïve ROS1‑positive NSCLC, and adjuvant osimertinib sustained OS benefit at 8 years.
    • Ivonescimab (PD‑1/VEGF bispecific) significantly improved overall survival versus pembrolizumab in PD‑L1–positive treatment‑naïve NSCLC (30.8 vs 22.6 months; HR 0.73) and gotistobart (engineered anti‑CTLA‑4) nearly doubled overall survival over docetaxel after PD‑(L)1 progression in metastatic squamous NSCLC (18.5 vs 10.0 months), with comparable safety for ivonescimab.
  • Emerging Themes & Macro-Trends
    • Precision‑first NSCLC is consolidating as frontline targeted approaches across HER2‑mutant, EGFR exon 20 insertion, and ROS1‑positive disease generate data supportive of imminent filings and guideline updates, while eight‑year ADAURA findings further entrench adjuvant osimertinib.
    • Portfolio strategies are pivoting away from unselected ADC–ICI combinations and routine post‑IO local consolidative therapy toward biomarker‑anchored ADC/TKI assets with CNS activity and IO programs designed with head‑to‑head PD‑1 comparators and global access strategies, given null survival for post‑IO LCT and the dominance of precision frontlines.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-09-01 and 2026-09-30 about non-small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • FDA granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for adult patients with locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) TKD activating mutations, expanding the indication to treatment‑naïve patients. The review was conducted under Project Orbis with the UK MHRA and received Priority Review, Breakthrough Therapy, and Orphan Drug designations. ¹ (read more)
  • Nuvation Bio announced FDA approval of a supplemental NDA for IBTROZI (taletrectinib) to update the U.S. label with longer duration-of-response data in TKI‑naïve advanced ROS1‑positive NSCLC. The company highlighted that the update fulfills a post‑marketing commitment tied to the original approval. ² (read more)
  • OncoC4 reported the FDA granted Fast Track designation to cesalatamig (AI‑081), a PD‑1/VEGF bispecific, for NSCLC that progressed after PD‑(L)1 therapy and platinum chemotherapy. The company said the designation supports expedited development as it advances toward registrational phase 3 studies. ³ (read more)
  • BlossomHill Therapeutics’ Q2 2026 update disclosed FDA Fast Track designation for BH‑30643, a macrocyclic OMNI‑EGFR inhibitor, for EGFR C797S‑positive NSCLC after third‑generation EGFR TKI therapy. The company also guided to a Q4 2026 End‑of‑Phase 1 FDA meeting to discuss RP2D and a potential accelerated approval pathway, with a pivotal phase 2 start planned for Q1 2027. ⁴ (read more)
  • At WCLC 2026, BlossomHill presented updated phase 1/2 SOLARA data in C797S‑positive NSCLC and reiterated the recent FDA Fast Track designation for BH‑30643. The company stated the data and designation support plans to advance to phase 2 in 2027. ⁵ (read more)
  • BeyondSpring announced FDA Fast Track designation for plinabulin plus docetaxel in post‑ICI non‑squamous NSCLC without actionable genomic alterations and detailed a strategic transaction to advance the global phase 3 DUBLIN‑4 trial toward its planned interim analysis. The company framed the Fast Track as an important regulatory milestone supporting expedited development. ⁶ (read more)
  • OncLive reported the FDA Fast Track designation for plinabulin plus docetaxel in post‑ICI non‑squamous NSCLC, noting DUBLIN‑4 is designed to serve as the global confirmatory study expected to support a future NDA. The article also highlighted the program’s rationale and prior DUBLIN‑3 and Study 303 data informing the phase 3 design. ⁷ (read more)
  • Targeted Oncology’s monthly recap noted September 2026 FDA oncology activity included accelerated approval of sevabertinib (Hyrnuo) in treatment‑naïve HER2‑mutant NSCLC. The roundup contextualized the lung cancer decision among other oncology approvals and regulatory moves during the month. ⁸ (read more)
  • Johnson & Johnson’s WCLC 2026 press release on RYBREVANT (amivantamab) and RYBREVANT FASPRO for EGFR‑mutated NSCLC reiterated U.S. FDA approvals and listed the specific NSCLC indications covered. The company positioned the data as reinforcing approved treatment options while showcasing ongoing development across IV and SC formulations. ⁹ (read more)
  • Georgetown Lombardi’s news release on the final PAPILLON trial results in EGFR exon 20 insertion‑positive NSCLC stated that earlier efficacy led to FDA approval of amivantamab (Rybrevant) in March 2024. The WCLC 2026 presentation was highlighted as confirming durable clinical benefit and the longest median overall survival reported to date for this population. ¹⁰ (read more)
Conference
Major Conference Updates
Conference Information
  • IASLC 2026 World Conference on Lung Cancer (WCLC); Seoul, Republic of Korea; September 12–15, 2026. (read more)
  • Overall sentiment: Precision-first NSCLC solidified (frontline targeted wins in defined genomics), next‑gen immunotherapies showed survival gains, while broad ADC–ICI combos and routine post‑IO consolidation were de‑emphasized. (read more)
  • Theme 1: Precision Frontlines in Genomically Defined NSCLC
    • Significance: Multiple positive readouts support immediate guideline updates and regulatory momentum for first‑line targeted strategies across HER2‑mutant, EGFR exon 20 insertion, and ROS1‑positive disease; durability confirmed in earlier‑stage EGFR‑mutant resection. (read more)
    • Mechanism insights / clinical impact: ADC and TKI differentiation drove effects—trastuzumab deruxtecan (T‑DXd) improved PFS vs chemo‑IO (14.3 vs 8.3 mo; HR 0.63) with manageable ILD risk; zipalertinib plus chemo extended PFS (14.5 vs 8.5 mo; HR 0.50) with high ORR; zidesamtinib showed 94% ORR and 100% intracranial ORR in TKI‑naïve ROS1+ disease; adjuvant osimertinib sustained long‑term OS benefit at 8 years. (read more)
    • Patient populations affected: 1L metastatic HER2‑mutant NSCLC (DESTINY‑Lung04), 1L EGFR exon 20 insertion NSCLC (REZILIENT 3), TKI‑naïve ROS1‑positive advanced NSCLC (ARROS‑1), completely resected stage IB–IIIA EGFR‑mutated NSCLC (ADAURA). (read more)
  • Theme 2: Beyond PD‑1—Bispecifics and Engineered CTLA‑4
    • Significance: First‑line chemotherapy‑free options and post‑PD-(L)1 strategies are expanding; survival improvements against pembrolizumab and docetaxel suggest near‑term regional standards and global development catalysts. (read more)
    • Mechanism insights / clinical impact: Ivonescimab (PD‑1/VEGF bispecific) improved OS vs pembrolizumab (30.8 vs 22.6 mo; HR 0.73) with comparable safety; gotistobart (anti‑CTLA‑4 engineered for Treg depletion) nearly doubled OS vs docetaxel post‑PD‑(L)1 progression (18.5 vs 10.0 mo). (read more)
    • Patient populations affected: Treatment‑naïve PD‑L1–positive advanced NSCLC without EGFR/ALK (HARMONi‑2; China to date), metastatic squamous NSCLC after PD‑(L)1 therapy (PRESERVE‑003). (read more)
  • Theme 3: ADC + ICI Recalibration in Unselected 1L Disease
    • Significance: Negative EVOKE‑03/KEYNOTE‑D46 for sacituzumab govitecan + pembrolizumab underscores that broad ADC–ICI doesn’t beat pembrolizumab monotherapy in PD‑L1‑high disease; portfolio focus should pivot to biomarker‑anchored ADCs or distinct MOAs. (read more)
    • Mechanism insights / clinical impact: Despite numerical trends, no statistically significant PFS/OS gains; exploratory regional signals (East Asia) were non‑prespecified and hypothesis‑generating only. (read more)
    • Patient populations affected: 1L metastatic NSCLC with PD‑L1 TPS ≥50%—single‑agent pembrolizumab remains SoC. (read more)
  • Theme 4: Post‑IO Local Consolidation De‑emphasized
    • Significance: LONESTAR showed no OS/PFS advantage for adding surgery/radiation after nivolumab + ipilimumab, challenging routine use of LCT in the IO era. (read more)
    • Mechanism insights / clinical impact: No survival benefit overall or in oligometastatic subsets; pneumonitis numerically higher and lymphocyte suppression observed after LCT—supporting systemic‑first paradigms. (read more)
    • Patient populations affected: Metastatic NSCLC, including oligometastatic, after dual‑IO induction. (read more)
  • Significance
    • Expected clinical or translational readouts: DESTINY‑Lung04 OS maturation; REZILIENT 3 OS; ARROS‑1 longer follow‑up; global ivonescimab programs; PRESERVE‑003 pivotal stage. (read more)
    • Regulatory or policy implications: T‑DXd likely to frontline labeling in HER2‑mutant NSCLC; zipalertinib + chemo poised for filings; adjuvant osimertinib further entrenched. (read more)
    • Potential shifts in standard of care: Precision frontline adoption across HER2m/EGFR Ex20ins; ivonescimab as regional 1L standard (China) with global potential; continued pembrolizumab monotherapy in PD‑L1‑high unselected patients. (read more)
    • Strategic implications: Prioritize biomarker‑defined ADC/TKI assets with CNS activity; de‑prioritize unselected ADC–ICI combos; design IO trials with head‑to‑head PD‑1 comparators and global access strategies; limit LCT post‑IO to protocols with strong selection biology. (read more)
Publications Related to Approved Drugs
Phase 3
osimertinib
Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA Non-Small Cell Lung Cancer: Exploratory 8-year Overall Survival Landmark Update from the ADAURA Trial [161/175]. A post hoc exploratory analysis from the ADAURA trial reports the longest overall survival (OS) data from a global phase 3 adjuvant study in EGFR-mutated NSCLC, showing a sustained OS benefit with adjuvant osimertinib versus placebo. At a median follow-up of 93.3 months for the stage IB-IIIA population, the 8-year OS rates were 79% for osimertinib versus 64% for placebo, further solidifying its role as a standard of care in this setting. () .
Phase 3
amivantamab, lazertinib
Long-Term Impact of First-Line Amivantamab Plus Lazertinib Versus Osimertinib on Mechanisms of Acquired Resistance in MARIPOSA: A Brief Report. In the MARIPOSA trial for first-line EGFR-mutated advanced NSCLC, amivantamab plus lazertinib significantly reduced the development of acquired resistance mechanisms, particularly MET amplifications and secondary EGFR mutations, compared to osimertinib. This alteration of the disease's biological evolution contributes to improved first-line efficacy and a substantially prolonged median second-line progression-free survival (8.4 vs. 5.3 months), highlighting a key strategic advantage for the combination therapy. () .
Phase 3
alectinib hydrochloride
Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial. In the ALINA trial for resected ALK-positive NSCLC, adjuvant alectinib demonstrated a manageable safety profile with fewer discontinuations due to adverse events compared to platinum-based chemotherapy (5% vs. 13%). Furthermore, alectinib was associated with clinically meaningful improvements in health-related quality of life, which were maintained over the two-year treatment period, supporting its use as a new standard of care alongside its established disease-free survival benefit. () .
Phase 3
osimertinib
Long-term safety of first-line osimertinib plus platinum-pemetrexed in EGFR-mutated advanced NSCLC: FLAURA2. A novel, longitudinal safety analysis from the FLAURA2 trial demonstrates the manageable long-term safety profile of adding platinum-pemetrexed to first-line osimertinib for EGFR-mutated advanced NSCLC. The frequency of new treatment-related adverse events was highest during the initial triple-combination induction phase and progressively decreased during the subsequent pemetrexed-maintenance and osimertinib-only periods, reinforcing the favorable long-term benefit-risk profile of this regimen. () .
Phase 3
durvalumab
Perioperative Durvalumab for Resectable NSCLC: Updated Outcomes for Japanese Patients in AEGEAN. A prespecified exploratory analysis of the Japanese subgroup from the AEGEAN study showed that perioperative durvalumab plus neoadjuvant chemotherapy resulted in a numerically higher pathological complete response (pCR) rate (33.3% vs. 5.9%) and a favorable event-free survival (EFS) benefit compared to neoadjuvant chemotherapy alone. These findings are consistent with or greater than those in the global population, supporting this regimen as a treatment option for Japanese patients with resectable NSCLC. () .
Phase 3
lorlatinib
Artificial intelligence-enabled early intracranial volumetric response predicts systemic progression-free survival in the phase III CROWN study. In an analysis of the CROWN trial for advanced ALK-positive NSCLC with brain metastases, an AI-powered platform demonstrated high concordance with neuroradiologists for intracranial response assessment. Importantly, early tumor response based on AI-driven volumetric analysis of all brain lesions was a significant predictor of systemic progression-free survival, outperforming standard RECIST-based measurements and offering a potential early prognostic tool. () .
Phase 3
durvalumab
Clinical outcomes by type of surgery with perioperative durvalumab in patients with resectable non-small cell lung cancer. A subgroup analysis from the AEGEAN study demonstrated that the clinical benefit of perioperative durvalumab with neoadjuvant chemotherapy was maintained across different types of surgical resection (lobectomy, sleeve resection/bilobectomy, and pneumonectomy). Higher pathological complete response rates and favorable event-free survival trends were observed in the durvalumab arm versus the placebo arm, regardless of the surgical procedure performed. () .
New Publications Related to Drugs in Clinical Trial Development
Phase 2
Single-arm, multicentre phase II trial of sintilimab plus platinum-based doublet chemotherapy followed by adaptive radiotherapy strategy for patients with unresectable stage III non-small-cell lung cancer in China: the ART-LUNG 01 study protocol. This publication outlines the study protocol for a phase II trial evaluating the efficacy and safety of sintilimab with induction chemotherapy followed by adaptive radiotherapy and consolidation sintilimab for unresectable stage III NSCLC, aiming to enhance tumor downstaging and immune synergy. ()
Phase 3
Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. The combination of ifebemtinib, a FAK inhibitor, and garsorasib, a KRAS G12C inhibitor, demonstrated an encouraging objective response rate of 82% with a manageable safety profile as a first-line, chemotherapy-free regimen for KRAS G12C-mutated NSCLC, prompting the initiation of a randomized phase 3 study. ()
PHASE1, PHASE2
Daraxonrasib for Previously Treated <i>RAS</i>-Mutant Non-Small-Cell Lung Cancer. In a phase 1-2 study, daraxonrasib, an oral RAS(ON) multi-selective inhibitor, demonstrated antitumor activity in over 30% of patients with previously treated metastatic RAS-mutant NSCLC, though adverse events of grade 3 or higher were reported in 54% of patients. ()
Phase 2
Evaluation of MET Detection Methods and Cutoffs in EGFR-Mutated Non-small Cell Lung Cancer Following Disease Progression on Osimertinib in the phase II SAVANNAH study. This analysis from the SAVANNAH study established that higher MET biomarker cutoffs (IHC3+/≥90% and/or FISH10+) are optimal for identifying patients with EGFR-mutated NSCLC most likely to respond to savolitinib plus osimertinib after progression on first-line osimertinib, informing the eligibility criteria for the subsequent phase III SAFFRON study. ()
Phase 2
Population Pharmacokinetics and Exposure-Response Analyses of Savolitinib Alone or in Combination With Osimertinib in Patients With Locally Advanced or Metastatic Solid Tumors. An integrated population pharmacokinetics and exposure-response analysis of savolitinib supports the current trough-driven dosing strategy, as no clear trend between exposure and efficacy was observed in patients with high MET biomarker status, suggesting sufficient target coverage is achieved. ()
Phase 3
Induction and consolidation atezolizumab with stereotactic body radiation therapy versus radiation alone in high-risk, early-stage non-small-cell lung cancer (SWOG/NRG S1914): a multicentre, open-label, superiority, phase 3, randomised controlled trial. This phase 3 trial in inoperable, early-stage NSCLC found no overall survival benefit from adding atezolizumab to stereotactic body radiation therapy (SBRT), and reported a higher rate of grade 3 or higher adverse events with the combination, leading to the trial's closure for futility. ()
PHASE1, PHASE2
FAK inhibitor and RAF/MEK clamp avutometinib enhance KRAS G12C inhibitor efficacy in preclinical models of non-small cell lung cancer. Preclinical data demonstrates that combining a RAF/MEK clamp (avutometinib) and a FAK inhibitor (defactinib) with a KRAS G12C inhibitor enhances antitumor activity by suppressing the MAPK pathway and inhibiting adaptive resistance, providing a strong rationale for the triplet combination's clinical evaluation. ()
Phase 2
Trastuzumab Deruxtecan in Patients From China With Pretreated HER2-Mutant Non-Small Cell Lung Cancer: Final Analysis of the Phase 2, Single-Arm DESTINY-Lung05 Trial. With extended follow-up, trastuzumab deruxtecan (T-DXd) continued to show clinically meaningful and durable antitumor activity (ORR 56.9%, median OS 21.0 months) in Chinese patients with pretreated HER2-mutant metastatic NSCLC, affirming its use as a treatment option in this population. ()
Phase 3
DESTINY-Lung06: trastuzumab deruxtecan and pembrolizumab as first-line treatment for HER2-overexpressing, PD-L1 TPS <50% NSCLC. This publication details the protocol for the DESTINY-Lung06 phase III trial, which will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) plus pembrolizumab versus pembrolizumab plus chemotherapy as a first-line treatment for patients with HER2-overexpressing NSCLC and low PD-L1 expression. ()
Phase 2
Prolonged survival after systemic immune reactivation by aglatimagene besadenovec plus valacyclovir in immune checkpoint inhibitor-refractory non-small cell lung cancer. In a single-arm phase 2a study, aglatimagene besadenovec plus valacyclovir was associated with systemic immune remodeling and encouraging survival (median OS 24.5 months in the per-protocol population) for patients with advanced NSCLC who have progressed on immune checkpoint inhibitors, warranting confirmation in a randomized trial. ()
Phase 2
Genomic Profiling of Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer after Progression on First-line Osimertinib: Phase II ORCHARD Study. This exploratory analysis of the ORCHARD study provides a comprehensive genomic landscape of resistance to first-line osimertinib, revealing that 87% of samples had detectable resistance alterations, often multiple, which supports combining treatments with broad activity to improve patient outcomes. ()
Phase 2
Comparative efficacy of taletrectinib versus first-generation TKIs in TKI-naïve ROS1+ non-small cell lung cancer: A matching-adjusted indirect comparison. A matching-adjusted indirect comparison of data from the TRUST-I and TRUST-II studies suggests that the next-generation ROS1 TKI taletrectinib is associated with more favorable response and survival outcomes compared to first-generation TKIs (crizotinib, entrectinib) in TKI-naïve patients with ROS1+ NSCLC. ()
Phase 2
Deulorlatinib (TGRX-326) in ALK Gene Fusion Positive NSCLC After Failure of Second-Generation Inhibitors: A Single-Arm, Multicenter, Phase 2 Trial. The third-generation ALK inhibitor deulorlatinib demonstrated encouraging antitumor activity (ORR 43.7%, median PFS 11.1 months) and a favorable safety profile in patients with advanced ALK-positive NSCLC who progressed after second-generation inhibitors, including those with the G1202R mutation. ()
Phase 3
Osimertinib With or Without Chemotherapy in Advanced Non-Small Cell Lung Cancer With EGFR and Concurrent TP53 Mutations: A Randomized Clinical Trial. In a phase 3 trial, first-line osimertinib plus chemotherapy significantly prolonged median progression-free survival compared to osimertinib monotherapy (34.0 vs 15.6 months) for patients with EGFR-mutated advanced NSCLC harboring concurrent TP53 mutations, supporting individualized combination strategies. ()
Phase 3
Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial. The HARMONi phase 3 trial showed that ivonescimab plus chemotherapy resulted in a statistically significant and clinically meaningful progression-free survival benefit (6.8 vs 4.4 months) compared to placebo plus chemotherapy for patients with EGFR-mutated NSCLC that progressed after third-generation EGFR-TKI therapy. ()
Phase 2
Comparative efficacy of taletrectinib versus first-generation TKIs in TKI-naïve ROS1+ non-small cell lung cancer: A matching-adjusted indirect comparison. A matching-adjusted indirect comparison using data from the TRUST-I and TRUST-II studies indicates that the next-generation ROS1 TKI taletrectinib is associated with superior response and survival outcomes compared to first-generation TKIs (crizotinib, entrectinib) for TKI-naïve patients with ROS1+ NSCLC. ()
Phase 2
A phase II multi-institutional single arm trial evaluating TG4010 vaccine plus nivolumab in non-small cell lung cancer. The combination of the MUC1 vaccine TG4010 with nivolumab showed limited clinical benefit in a phase II study for ICI-naïve NSCLC patients, with only one exceptional responder, suggesting further study is needed to optimize its efficacy, potentially in combination with cytotoxic therapy or in specific patient subgroups. ()
Phase 3
Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin® and US-Avastin® in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. A unified population pharmacokinetic model demonstrated that the bevacizumab biosimilar CT-P16 has comparable pharmacokinetics to both EU-Avastin® and US-Avastin®, with no clinically meaningful differences, supporting the totality of evidence for biosimilarity. ()
Phase 2
PD-L1 PET/CT imaging with 18F-BMS-986,229 and 18F-BMS-986,192 in patients with advanced-stage non-small cell lung cancer. In this study, two novel PD-L1 PET tracers performed equally with respect to tumor uptake, but this uptake did not correlate with PD-L1 IHC expression; however, an exploratory analysis suggested low tracer uptake may be associated with shorter overall survival, warranting further investigation. ()
Phase 3
Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non-Small Cell Lung Cancer: Post Hoc Analysis of the Neotorch Randomized Clinical Trial. This post hoc analysis of the Neotorch trial found that perioperative toripalimab plus chemotherapy led to significantly higher rates of tumor and lymph node downstaging compared to chemotherapy alone, which was associated with improved event-free survival without increasing surgical complications. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in non-small cell lung cancer updated from 2026-09-01 to 2026-09-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation-------
Not Yet Recruiting6418-7237
Recruiting4338446372170
Available-------
Approved for Marketing-------
Active, Not Recruiting201733222195
Completed321-2-8
Total7261968685310
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
AI-061 NCT05858736 COMPLETED Safety, Pharmacokinetics (PK) and Efficacy of AI-061, A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC-392 (Anti-CTLA-4) Antibodies in Advanced Solid Tumors: An Open-Label Phase 1 Study 2026-07-31
[14C]Zorifertinib Oral Formulation NCT07620951 COMPLETED Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China 2026-08-03
RAD301 ([68Ga]-RAD301) NCT05799274 ACTIVE_NOT_RECRUITING Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors 2026-09
: PRTH-101, : Pembrolizumab NCT05753722 COMPLETED An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors 2026-09-02
PF-07934040, Oxaliplatin, Bevacizumab, Nab-paclitaxel, Carboplatin, pemetrexed, Sasanlimab, Fluorouracil, Paclitaxel, Pembrolizumab, Cetuximab, Cisplatin, Leucovorin, Gemcitabine NCT06447662 ACTIVE_NOT_RECRUITING A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene 2026-10-09
[89Zr]Zr- BI 770371, [89Zr]Zr- BI 765063, Ezabenlimab, BI 765063, BI 770371 NCT05068102 ACTIVE_NOT_RECRUITING An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With Ezabenlimab 2026-11-25
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
PD-1/PD-L1 inhibitor plus chemotherapy NCT06501378 COMPLETED Cranial Radiotherapy Plus PD-1/PD-L1 Inhibitors and Chemotherapy in Untreated Driver-mutation Negative Non-small Cell Lung Cancer With Active Brain Metastasis (BRILLIANT-1) 2026-09-01
: Pembrolizumab NCT04032418 ACTIVE_NOT_RECRUITING Randomized Phase II Study of Pembrolizumab 200mg every12 Weeks Versus Every 3 Weeks in NSCLC With Clinical Benefit to Pembrolizumab Monotherapy: Multicenter International Study 2026-09-14
Gemcitabine+carboplatin, Nab-paclitaxel+carboplatin, Placebo for Olaparib, Durvalumab, Olaparib, Gemcitabine+cisplatin, Pemetrexed+cisplatin, Pemetrexed+carboplatin NCT03775486 ACTIVE_NOT_RECRUITING A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION) 2026-09-27
INCB099280 NCT05879822 ACTIVE_NOT_RECRUITING A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive 2026-09-30
Atezolizumab, Cobimetinib NCT03600701 ACTIVE_NOT_RECRUITING A Phase 2 Study of Atezolizumab and Cobimetinib in PD-1/PD-L1 Inhibitor Resistant or Refractory Non-Small Cell Lung Cancer 2026-10-03
Adagrasib NCT05673187 ACTIVE_NOT_RECRUITING A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status 2026-12
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Pemetrexed, Atezolizumab, Vinorelbine, Docetaxel, Cisplatin, Gemcitabine NCT02486718 COMPLETED A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer 2026-08-26
MEDI4736 NCT02273375 COMPLETED A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer 2026-09-01
JDQ443, docetaxel NCT05132075 ACTIVE_NOT_RECRUITING A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer 2026-10-03
Avelumab NCT03815643 ACTIVE_NOT_RECRUITING An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies 2026-11-24
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
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