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NSCLCJune 2026
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Non-Small Cell Lung Cancer — Monthly Compass
Jun 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
    • ASCO’s June 2026 living‑guideline update for advanced NSCLC without driver alterations added retifanlimab to treatment options.
  • Important Drug Publication Updates
    • In JCO, the PD‑L1–directed vedotin ADC PDL1V (PF‑08046054) demonstrated ctDNA reductions concordant with radiographic responses in NSCLC, supporting on‑target payload delivery and biomarker‑anchored assessment.
    • A JCO individual‑patient‑data survival analysis and meta‑analysis strengthened comparative evidence favoring TROP2 antibody–drug conjugates over chemotherapy in advanced NSCLC.
  • Key Clinical Development Updates
    • GSK’s agreement to acquire Nuvalent highlighted two NSCLC candidates under FDA review—zidesamtinib (ROS1) with a September 18, 2026 target action date and neladalkib (ALK) with a November 27, 2026 target—both with Breakthrough Therapy and Orphan Drug designations and anticipated 2026 launches pending approval.
    • Regulators and sponsors advanced multiple NSCLC programs: Verastem received FDA Fast Track for the KRAS G12D ON/OFF inhibitor VS‑7375 for KRAS G12D‑mutated unresectable locally advanced or metastatic NSCLC after platinum and anti‑PD‑(L)1 therapy and initiated the registration‑directed Phase 2 TARGET‑D‑202 while continuing Phase 1 TARGET‑D‑101; Candel opened the global pivotal Phase 3 AURORA trial of aglatimagene besadenovec (CAN‑2409) plus valacyclovir with continued pembrolizumab versus docetaxel with overall survival as the primary endpoint in metastatic non‑squamous NSCLC after inadequate ICI response; MAIA obtained FDA clearance to expand U.S. enrollment and reported completion of international Part C enrollment for the Phase 2 THIO‑101 third‑line study; Nuvation’s taletrectinib MAA for advanced ROS1+ NSCLC was validated by the U.K. MHRA under the International Recognition Procedure; and Calidi received positive FDA pre‑IND feedback for CLD‑401 with alignment on CMC, nonclinical plans, and first‑in‑human study design.
  • Key Conference Updates
    • In HARMONi‑6 (AK112‑306), ivonescimab plus chemotherapy reduced the risk of death versus tislelizumab plus chemotherapy in first‑line squamous NSCLC (OS HR 0.66) with 24‑month OS 64.7% versus 48.6% and acceptable safety in a Chinese cohort.
    • The COPERNICUS program reported early safety for first‑line subcutaneous amivantamab plus lazertinib and interim results for subcutaneous amivantamab plus chemotherapy using enhanced dermatologic and VTE prophylaxis, supporting pragmatic deployment across multinational EGFR‑mutated NSCLC settings.
  • Emerging Themes & Macro-Trends
    • June 2026 NSCLC development emphasized ADC diversification beyond TROP2 anchored by translational biomarkers such as ctDNA and access‑oriented subcutaneous delivery of EGFR/MET bispecifics.
    • Perioperative precision is advancing with HER2‑selective TKI strategies entering global adjuvant trials in completely resected stage II–IIIB ERBB2‑mutant NSCLC.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-06-01 and 2026-06-30 about non-small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • MAIA Biotechnology announced the FDA cleared an amendment to its IND enabling U.S. enrollment expansion of the Phase 2 THIO-101 trial of ateganosine (THIO) in advanced NSCLC; the company noted Fast Track Designation (July 2025) and that additional data may support a potential Accelerated Approval filing. The update emphasizes U.S. site activations and manufacturing/formulation enhancements under the amended IND. (globenewswire.com) ¹ (read more)
  • Verastem Oncology reported the FDA granted Fast Track Designation to VS-7375, an oral KRAS G12D ON/OFF inhibitor, for KRAS G12D‑mutated unresectable locally advanced or metastatic NSCLC after platinum and anti‑PD‑(L)1 therapy. The company highlighted its ongoing Phase 1 TARGET‑D‑101 and the initiation of a Phase 2 registration‑directed TARGET‑D‑202 study in NSCLC. (investor.verastem.com) ² (read more)
  • GSK announced an agreement to acquire Nuvalent and highlighted two NSCLC candidates under FDA review with target decision dates: zidesamtinib (ROS1 inhibitor) on September 18, 2026 and neladalkib (ALK inhibitor) on November 27, 2026. Both programs were described as having FDA Breakthrough Therapy and Orphan Drug designations, with anticipated 2026 launches pending approval. (us.gsk.com) ³ (read more)
  • Calidi Biotherapeutics disclosed positive FDA pre‑IND meeting feedback for CLD‑401 (targets NSCLC, head & neck, and other tumors), with alignment on CMC, nonclinical plans, and first‑in‑human study design. The candidate remains in IND‑enabling studies as the company advances toward clinical entry. (ir.calidibio.com) ⁴ (read more)
  • Nuvation Bio announced MHRA validation of the taletrectinib MAA for advanced ROS1+ NSCLC via the U.K.’s International Recognition Procedure, noting expedited assessment based on trusted regulator decisions. The release reiterates prior U.S. FDA regulatory milestones for taletrectinib, including Priority Review and double Breakthrough Therapy designations leading to full approval in June 2025. (prnewswire.com) ⁵ (read more)
  • Candel Therapeutics initiated the global pivotal Phase 3 AURORA trial in metastatic, non‑squamous NSCLC with inadequate response to ICIs; the company reiterated that the FDA previously granted Fast Track Designation to aglatimagene besadenovec (CAN‑2409) for NSCLC. The study will compare aglatimagene plus valacyclovir with continued pembrolizumab versus docetaxel, with overall survival as the primary endpoint. (globenewswire.com) ⁶ (read more)
  • MAIA Biotechnology reported completion of international enrollment for Part C of the Phase 2 THIO‑101 expansion trial in third‑line NSCLC, and referenced its FDA Fast Track Designation for ateganosine. The company added that the designation may expedite a potential Accelerated Approval and Priority Review pathway as data mature. (globenewswire.com) ⁷ (read more)
Conference
Major Conference Updates
Conference Information
  • 2026 ASCO Annual Meeting; Chicago, Illinois; May 29–June 2, 2026. (read more)
  • Overall: June 2026 outputs in NSCLC spotlighted three inflection points—angio‑immuno bispecifics achieving first-line OS gains in squamous disease, ADCs diversifying beyond TROP2 with translational biomarkers, and perioperative HER2 targeting advancing into adjuvant trials—alongside access‑oriented delivery (subcutaneous EGFR/MET bispecifics). (read more)
  • Theme 1: PD‑1/VEGF Bispecifics Achieve First‑Line OS Benefit in Squamous NSCLC
    • Significance: Validates dual angiogenesis–checkpoint targeting as a differentiation path vs PD‑1 plus chemotherapy comparators; positions ivonescimab regimens for potential guideline and reimbursement impact (China-first, global ripple effects). (read more)
    • Mechanism insights / clinical impact: In HARMONi‑6 (AK112–306), ivonescimab plus chemotherapy reduced death risk vs tislelizumab plus chemotherapy (OS HR 0.66); 24‑month OS 64.7% vs 48.6%, supporting durable benefit with acceptable safety. (read more)
    • Patient populations affected: Treatment‑naïve, advanced squamous NSCLC; data generated in a Chinese cohort with PD‑L1–agnostic efficacy signals. (read more)
  • Theme 2: ADC Diversification with Translational Biomarkers
    • Significance: Movement beyond TROP2 consolidates ADCs as a post‑platinum/immunotherapy pillar while enabling earlier efficacy readouts via ctDNA. (read more)
    • Mechanism insights / clinical impact: PDL1V (PF‑08046054), a first‑in‑class PD‑L1–directed vedotin ADC, showed ctDNA reductions aligned with radiographic response, supporting on‑target payload delivery; concurrent individual‑patient‑data meta‑analysis of TROP2 ADCs strengthens comparative evidence vs chemotherapy. (read more)
    • Patient populations affected: Advanced/metastatic NSCLC, largely post‑standard therapy; biomarker exploration (PD‑L1 expression, ctDNA kinetics) may refine selection. (read more)
  • Theme 3: Perioperative Precision—HER2 TKI Moves Upstream
    • Significance: Beamion LUNG‑3 (NCT07195695) initiates adjuvant testing of zongertinib vs standard of care, signaling a shift toward genotype‑directed cure strategies in early‑stage disease. (read more)
    • Mechanism insights / clinical impact: HER2‑selective, EGFR‑sparing inhibition builds on activity seen in advanced settings and may address systemic and CNS relapse risk if positive. (read more)
    • Patient populations affected: Completely resected stage II–IIIB, HER2 (ERBB2) TKD‑mutant NSCLC; global, multi‑center enrollment. (read more)
  • Theme 4: Access‑Oriented Delivery—Subcutaneous Amivantamab Programs
    • Significance: SC administration aims to cut chair time and improve tolerability through pragmatic prophylaxis frameworks, widening frontline reach. (read more)
    • Mechanism insights / clinical impact: COPERNICUS reports early safety for first‑line subcutaneous amivantamab plus lazertinib and interim results for SC amivantamab plus chemotherapy with enhanced dermatologic/VTE prophylaxis, supporting real‑world deployability. (read more)
    • Patient populations affected: EGFR‑mutated advanced NSCLC, first‑ and second‑line cohorts across multinational, practice‑reflective settings. (read more)
  • Significance
    • Expected clinical or translational readouts: Full HARMONi‑6 publication/updates and China regulatory steps; expanding phase 1/2 PD‑L1 ADC cohorts with ctDNA‑anchored endpoints; early operational milestones from Beamion LUNG‑3. (Inference based on June 2026 OS disclosure, ongoing trials, and June launches.) (read more)
    • Regulatory or policy implications: ASCO’s June living‑guideline update (driver‑negative) reflects rapid checkpoint landscape evolution; ivonescimab OS data could catalyze country‑specific guideline changes. (read more)
    • Potential shifts in standard of care: PD‑1/VEGF bispecific plus chemotherapy poised to redefine first‑line squamous NSCLC (China); positive Beamion LUNG‑3 would open adjuvant, mutation‑selected pathways. (read more)
    • Strategic implications: Prioritize bispecifics with validated biology, ADCs with translational selection (ctDNA/PD‑L1), and formulation innovations (SC) to differentiate on efficacy, safety management, and access. (ascopubs.org) (read more)
Publications Related to Approved Drugs
Phase 3
osimertinib
Patient-reported outcomes from the LAURA study: osimertinib in patients with unresectable stage III EGFR-mutated non-small cell lung cancer after definitive chemoradiotherapy. Patient-reported outcomes from the Phase III LAURA study demonstrate that health-related quality of life was maintained in patients with unresectable stage III EGFR-mutated NSCLC receiving osimertinib after chemoradiotherapy. These data, in conjunction with the significant progression-free survival benefit and a manageable safety profile, support osimertinib as a new standard of care in this setting. ()
Phase 3
alectinib hydrochloride
Disease characteristics and treatment outcomes in patients with resected early-stage ALK-positive non-small cell lung cancer from the randomized ALINA trial. An exploratory analysis of the Phase III ALINA trial confirms a consistent and significant disease-free survival benefit with adjuvant alectinib compared to platinum-based chemotherapy in patients with resected early-stage ALK-positive NSCLC. This benefit holds true regardless of disease stage (per AJCC 8th edition), nodal status, or tumor size, solidifying alectinib's role in the adjuvant setting. ()
PHASE1, PHASE2, PHASE3
pemetrexed disodium, pemetrexed, selpercatinib
Efficacy of selpercatinib as a first-line treatment for RET-fusion positive non-small-cell lung cancer: a novel two-stage Bayesian network meta-analysis. A novel two-stage Bayesian network meta-analysis, using data from the single-arm LIBRETTO-001 trial, demonstrated superior efficacy for first-line selpercatinib over standard chemotherapy in RET-fusion positive NSCLC. This work validates a new methodology for incorporating single-arm trial data into comparative analyses, potentially accelerating health technology assessments for drugs with this type of evidence. (, , )
New Publications Related to Drugs in Clinical Trial Development
Phase 2
High-dose furmonertinib as first-line treatment for untreated EGFR-mutated advanced NSCLC with central nervous system metastases: A phase 2 trial. High-dose furmonertinib (160 mg daily) demonstrates promising intracranial efficacy and a manageable safety profile as a first-line treatment for patients with EGFR-mutated NSCLC and CNS metastases. The study reported a median progression-free survival of 16.59 months and an intracranial objective response rate of 95.0%. ()
Phase 3
Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. In the first-line setting for PD-L1-positive advanced NSCLC, the combination of sacituzumab tirumotecan (a TROP2-targeting ADC) and pembrolizumab significantly prolonged progression-free survival compared to pembrolizumab alone (not reached vs 5.7 months). This combination has the potential to redefine the standard of care for this patient population. ()
Phase 3
Optimal Use of Targeted Therapy and Immunotherapy in Early-Stage, Resectable Non-Small Cell Lung Cancer. This article discusses the evolving landscape of systemic therapies for early-stage, resectable NSCLC, highlighting the approvals of adjuvant osimertinib and alectinib for EGFR/ALK-mutated disease and the established benefit of chemoimmunotherapy. It frames two critical, unanswered questions for ongoing trials: the optimal timing of chemoimmunotherapy (adjuvant vs. neoadjuvant/perioperative) and the utility of adjuvant immunotherapy for patients achieving a pathologic complete response. ()
Phase 2
Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. In a crossover study, 65% of participants with advanced cancers, including NSCLC, preferred the subcutaneous (SC) administration of pembrolizumab over the intravenous (IV) route, primarily due to less time spent in the clinic. The SC formulation improves convenience and was the chosen method for continued treatment by 68% of participants. ()
Phase 2
Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: pooled analysis of phase I and phase II trials. In a pooled analysis of heavily pretreated patients with EGFR-mutated NSCLC who progressed on prior TKI therapy, the bispecific ADC Izalontamab brengitecan demonstrated promising antitumor activity with a confirmed objective response rate of 47.4% and a median progression-free survival of 6.9 months. The safety profile was manageable, suggesting potential for this agent in a setting with limited options. ()
Phase 2
Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study. In patients with resectable stage IIIA-IIIB NSCLC, neoadjuvant camrelizumab plus chemotherapy resulted in a pathological complete response (pCR) rate of 33.3% and a 2-year disease-free survival (DFS) rate of 77.4%. Exploratory biomarker analysis identified that baseline CD8+ naïve-like T-cell abundance, circulating CCL3 levels, and post-treatment ctDNA dynamics may serve as potential prognostic markers for response and survival. ()
Phase 2
Durvalumab plus etoposide-platinum in patients with epidermal growth factor receptor (EGFR)-mutated advanced NSCLC and neuroendocrine transformation after first-line osimertinib: ORCHARD. For patients with EGFR-mutated NSCLC that transformed to neuroendocrine carcinoma after progressing on first-line osimertinib, the combination of durvalumab plus etoposide-platinum demonstrated a modest treatment response. The regimen yielded a confirmed objective response rate of 43% and a median progression-free survival of 4.2 months, with a safety profile consistent with the known toxicities of the individual agents. ()
Phase 2
Osimertinib plus selumetinib in patients with EGFR-mutated advanced NSCLC with BRAF alterations post-progression on first-line osimertinib: ORCHARD. The combination of osimertinib plus the MEK inhibitor selumetinib showed minimal clinical activity in patients with EGFR-mutated NSCLC who developed BRAF alterations after progressing on first-line osimertinib. With an objective response rate of only 7%, the study concluded that the risk-benefit profile does not warrant further evaluation of this combination. ()
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 the TROP2-directed ADC datopotamab deruxtecan (Dato-DXd) demonstrated clinical benefit for patients with EGFR-mutated NSCLC who progressed on first-line osimertinib. While the 6 mg/kg dose of Dato-DXd was associated with more frequent and severe adverse events, it is suggested as the preferred starting dose given the overall benefit-risk profile, including a median PFS of 11.7 months. ()
Phase 3
Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China. In the first-line treatment of advanced squamous NSCLC, the PD-1/VEGF bispecific antibody ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to tislelizumab plus chemotherapy (median OS 27.9 vs 23.7 months). This regimen could provide a novel first-line treatment option for this patient population. ()
Phase 3
Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. As a first-line treatment for advanced EGFR-mutated NSCLC, aumolertinib combined with chemotherapy significantly improved progression-free survival compared to aumolertinib monotherapy (28.9 months vs. 18.9 months). Although the combination regimen was associated with increased toxicity, the side effects were manageable, providing a new therapeutic option for this patient population. ()
Phase 2
Circulating CD28-KLRG1+CD8+ T cells involve in systemic and local immunity that predicts chemoimmunotherapy outcomes in advanced NSCLC. This study identifies circulating CD28-KLRG1+CD8+ T cells as a valuable and convenient biomarker for predicting outcomes in advanced NSCLC patients receiving first-line chemoimmunotherapy. These late-differentiated T cells were found to be clonally expanded and reinvigorated during treatment, serving as a peripheral pool for tumor-reactive T cells. ()
Phase 2
Long-Term Efficacy and Safety of Taletrectinib in Patients With <i>ROS1</i>+ Non-Small Cell Lung Cancer: Results From the Phase II TRUST-I Study. With long-term follow-up, the next-generation ROS1 TKI taletrectinib continued to demonstrate high and durable response rates in both TKI-naïve and crizotinib-pretreated patients with ROS1+ NSCLC. In TKI-naïve patients, the median progression-free survival exceeded four years (49.6 months), confirming its robust efficacy and manageable safety profile. ()
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 pH-sensitive anti-CTLA-4 antibody, showed clinically meaningful benefit in patients with metastatic squamous NSCLC who had progressed on prior PD-1/L1 inhibitor and platinum-based chemotherapy. In the stage 1 analysis, gotistobart demonstrated a significant overall survival advantage over docetaxel (median OS not reached vs. 10.0 months), with a manageable safety profile. ()
Phase 2
ctDNA-Based MRD Detection in Stage III NSCLC Treated With Chemoradiotherapy and Durvalumab. In patients with unresectable stage III NSCLC treated with CRT followed by durvalumab, detectable circulating tumor DNA (ctDNA) during and after durvalumab consolidation was strongly associated with a higher risk of progression and markedly shorter progression-free survival. This suggests that serial ctDNA-based minimal residual disease (MRD) assessment can identify high-risk patients who may benefit from intensified treatment strategies. ()
PHASE1, PHASE2
A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours. The anti-PD-1 antibody OSE-279 was well tolerated and showed durable responses in patients with advanced solid tumors, including NSCLC. Two recommended phase 2 doses were established (300 mg q3w and 600 mg q6w), and the trial is now evaluating OSE-279 in combination with a cancer vaccine for first-line, PD-L1 ≥ 50% NSCLC. ()
Phase 3
Optimal Use of Targeted Therapy and Immunotherapy in Early-Stage, Resectable Non-Small Cell Lung Cancer. This article reviews the expanding role of systemic therapy in early-stage, resectable NSCLC, noting the FDA approval of adjuvant osimertinib and alectinib for EGFR and ALK-mutated disease, respectively, and the established benefit of chemoimmunotherapy combinations. It highlights two ongoing clinical trials designed to answer critical questions regarding the optimal timing of chemoimmunotherapy (perioperative vs. adjuvant) and the necessity of adjuvant immunotherapy for patients who achieve a pathologic complete response. ()
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. In the final analysis with extended follow-up, trastuzumab deruxtecan (T-DXd) at 5.4 mg/kg continued to show durable and clinically meaningful antitumor activity in pretreated Chinese patients with HER2-mutant metastatic NSCLC. The study reported a confirmed objective response rate of 56.9% and a median overall survival of 21.0 months, affirming its use as a standard treatment option in this population. ()
Phase 1
First-in-human study of lomvastomig, a PD-1-TIM-3 bispecific antibody, in patients with advanced and/or metastatic solid tumors. The PD-1/TIM-3 bispecific antibody lomvastomig had a tolerable safety profile but showed limited clinical activity in checkpoint inhibitor-experienced melanoma and NSCLC patients. However, an encouraging signal was observed in CPI-naïve patients with esophageal squamous cell carcinoma (20% ORR), suggesting its potential in specific, less heavily pretreated populations. ()
PHASE2, PHASE3
Tiragolumab Plus Atezolizumab and Chemotherapy for Advanced Nonsquamous Non-Small Cell Lung Cancer: The Phase 3 SKYSCRAPER-06 Randomized Clinical Trial. The addition of the anti-TIGIT antibody tiragolumab to atezolizumab and chemotherapy did not improve progression-free survival or overall survival compared to a standard-of-care regimen of pembrolizumab plus chemotherapy in the first-line treatment of advanced nonsquamous NSCLC. The study failed to meet its primary endpoints and has been terminated. ()
Phase 2
ENTRÉE Lung Platform Trial Sub-study 1: Phase II Randomized Efficacy and Safety Analysis of Feladilimab Plus Docetaxel Versus Docetaxel Monotherapy in Advanced/Recurrent NSCLC. In patients with advanced NSCLC who had progressed on prior immunotherapy and platinum-based chemotherapy, adding the ICOS agonist feladilimab to docetaxel did not improve overall survival, progression-free survival, or tumor response compared to docetaxel alone. While the combination had an acceptable safety profile, it demonstrated no efficacy advantages in this second-line setting. ()
Phase 3
RATIONALE-303: Long-Term Outcomes of Tislelizumab in Previously Treated Advanced/Metastatic NSCLC. With an extended follow-up of nearly four years, tislelizumab continued to demonstrate clinically meaningful and durable improvements in overall survival compared to docetaxel for previously treated advanced NSCLC (median OS 16.9 vs 11.9 months). The long-term data confirm a favorable safety profile and establish tislelizumab as a key second-line treatment option. ()
Phase 3
Multitask learning of longitudinal circulating biomarkers and clinical outcomes: identification of optimal machine-learning and deep-learning models. This study evaluated machine-learning models to predict survival using longitudinal biomarker data from the SQUIRE trial in squamous NSCLC. A model combining multivariate functional principal component analysis with Cox regression (MFPCA-Cox) provided the highest predictive accuracy, outperforming advanced deep-learning algorithms and confirming that longitudinal models are superior to baseline-only models for survival prediction. ()
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. At 4-year follow-up, first-line tislelizumab plus chemotherapy continued to show a durable overall survival and progression-free survival benefit compared to chemotherapy alone in patients with advanced squamous NSCLC, despite a high crossover rate from the chemotherapy arm. The 4-year OS rates were 32.2% (tislelizumab/paclitaxel/carboplatin) and 26.0% (tislelizumab/nab-paclitaxel/carboplatin) versus 19.2% (chemotherapy alone), confirming the long-term value of this combination. ()
Phase 3
First-line atezolizumab monotherapy vs . single-agent chemotherapy in patients with advanced or metastatic non-small cell lung cancer who are ineligible for platinum-based therapy: Analysis of the IPSOS Asian subpopulation. In an Asian subpopulation of patients with advanced NSCLC ineligible for platinum-based chemotherapy, first-line atezolizumab monotherapy showed encouraging efficacy and better tolerability compared to single-agent chemotherapy. The findings, consistent with the global study population, reported a median overall survival of 15.8 months with atezolizumab versus 12.5 months with chemotherapy. ()
Phase 2
ELIOS: A Multicenter, Molecular Profiling Study of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer Treated with First-Line Osimertinib. This prospective study characterized acquired resistance mechanisms to first-line osimertinib in EGFR-mutant NSCLC using paired tumor biopsies, identifying MET amplification (17%) and EGFR C797S (13%) as common alterations. Proteogenomic analysis also revealed high TROP2 expression at baseline and post-progression, highlighting the potential for heterogeneous resistance and the need for broad-acting treatment strategies. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in non-small cell lung cancer updated from 2026-06-01 to 2026-06-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1-----1
Not Yet Recruiting411313224
Recruiting26141844167
Available-------
Approved for Marketing-------
Active, Not Recruiting8521-11-45
Completed-12-2-5
Total3921545203142
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
No phase 1 trials completing within the next three months.
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: Nivolumab, Pemetrexed, Carboplatin, : Relatlimab, Nab-Paclitaxel, Cisplatin, Paclitaxel NCT04623775 COMPLETED A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) 2026-05-06
Brigatinib, Tyrosine kinase inhibitor NCT04318938 COMPLETED Advancing Brigatinib Properties in Anaplastic Lymphoma Kinase Positive Non-small Cell Lung Cancer (ALK+ NSCLC) Patients 2026-05-30
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Lazertinib 240 mg/160 mg, Gefitinib 250 mg, Lazertinib-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg NCT04248829 COMPLETED A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib Versus Gefitinib as the First-line Treatment in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer 2026-04-22
Crizotinib, Alectinib NCT02838420 COMPLETED Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer 2026-05-11
SY-5007 NCT06031558 ACTIVE_NOT_RECRUITING A Phase III, Open-Label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC. 2026-06-20
Gemcitabine + carboplatin, Gemcitabine + cisplatin, Durvalumab (MEDI4736), Pemetrexed + carboplatin, Paclitaxel + carboplatin, Pemetrexed + cisplatin NCT03003962 ACTIVE_NOT_RECRUITING A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer 2026-06-30
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 2026-08-21
Vilanterol and Umeclidinium Bromide NCT04536675 ACTIVE_NOT_RECRUITING Effect of Perioperative Fixed-dose Dual Bronchodilator Therapy on Post-operative Pulmonary Function Among Mild- to -Moderate COPD Patients Undergoing Lung Cancer Surgery 2026-09
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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