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Non-Small Cell Lung Cancer — Monthly Compass
Jul 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.
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non-small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • On July 22, 2026, the FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1‑positive NSCLC after at least one prior ROS1 TKI, establishing a targeted second‑line standard with 44% ORR in ARROS‑1 following an RTOR/Assessment Aid review completed two months ahead of goal.
    • ASCO Living Guideline v2026.3.3 (July 24, 2026) for stage IV NSCLC without driver alterations aligned with July evidence emphasizing cancer‑type–specific, tumor‑intrinsic predictors beyond PD‑L1 to refine immunotherapy selection.
  • Important Drug Publication Updates
    • The Lancet Respiratory Medicine published first‑line KRAS G12C–mutant NSCLC data for ifebemtinib (IN10018) plus garsorasib, featuring promising anticancer activity.
  • Key Clinical Development Updates
    • GSK completed its acquisition of Nuvalent on July 15, 2026 and stated that zidesamtinib (ROS1) and neladalkib (ALK) for NSCLC were under FDA review with target decision dates later in 2026, with both programs holding Breakthrough Therapy and Orphan Drug Designations.
    • Ifebemtinib holds U.S. FDA Fast Track Designation and is advancing into a randomized phase 3 trial intended to support broader regulatory engagement in KRAS G12C–mutant NSCLC.
  • Key Conference Updates
    • ASCO Breakthrough (JCO 44:19_suppl, July 1, 2026) highlighted a tumor‑intrinsic glycosylation program identifying an immune‑cold, ICB‑resistant NSCLC subset and an “IOSelect‑lung” model with predictive value beyond current biomarkers, with smoking status modulating first‑line ICI effect sizes in Asian cohorts.
    • The ATORG Asia‑Pacific consensus reported MRD assays in early‑stage NSCLC have high specificity and positive predictive value but variable sensitivity, endorsing monitoring and trial use while discouraging routine adjuvant de‑escalation outside studies.
  • Emerging Themes & Macro-Trends
    • July outputs prioritize validation of glycosylation‑based and multi‑omics signatures, investment in ctRNA/MRD infrastructure with trial‑linked utility, and portfolio differentiation via post‑TKI combinations and driver‑specific assets tailored to regional populations.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On July 22, 2026, the FDA approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who had previously received at least one ROS1 tyrosine kinase inhibitor. Efficacy was evaluated in the ARROS-1 trial, showing an overall response rate of 44% in the efficacy population. The prescribing information includes warnings for central nervous system adverse reactions, QTc interval prolongation, interstitial lung disease/pneumonitis, skeletal fractures, myalgia with creatine phosphokinase elevation, pancreatic toxicity, and embryo-fetal toxicity.¹ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1‑positive NSCLC after at least one prior ROS1 TKI; the review used Real‑Time Oncology Review and the Assessment Aid and was completed two months ahead of the FDA goal date. Label warnings include CNS adverse reactions, QTc prolongation, ILD/pneumonitis, fractures, myalgia/CPK elevation, pancreatic toxicity, and embryo‑fetal toxicity. (fda.gov) ¹ (read more)
  • GSK announced FDA approval of Jideytro (zidesamtinib) for previously treated ROS1‑positive NSCLC, noting the action occurred ahead of the original PDUFA target action date of September 18, 2026. The company highlighted prior Breakthrough Therapy and Orphan Drug Designations for the program. (gsk.com) ² (read more)
  • GSK completed its acquisition of Nuvalent on July 15, 2026 and stated that zidesamtinib (ROS1) and neladalkib (ALK) for NSCLC are under FDA review with target decision dates later in 2026, signaling pending PDUFA timelines. The company also referenced prior Breakthrough Therapy and Orphan Drug Designations for both assets. (gsk.com) ³ (read more)
  • InxMed reported publication of first‑line KRAS G12C–mutant NSCLC data for ifebemtinib (IN10018) plus garsorasib and noted that ifebemtinib has Fast Track Designation from the U.S. FDA. The company is advancing a randomized phase 3 trial intended to support broader regulatory engagement. (prnewswire.com) ⁴ (read more)
  • ASCO Policy News covered the FDA’s July 22, 2026 approval of zidesamtinib for previously treated ROS1‑positive NSCLC and explicitly noted the use of the Real‑Time Oncology Review pilot and the Assessment Aid in the application’s review. (asco.org) ⁵ (read more)
Conference
Major Conference Updates
Conference Information
  • 2026 ASCO Breakthrough (Proceedings published in Journal of Clinical Oncology, Vol 44, Issue 19_suppl, July 1, 2026); location: Singapore (press briefing coverage). (read more)
  • Overall sentiment: July outputs emphasize smarter immunotherapy selection via tumor-intrinsic biology, rapid adoption of liquid-biopsy/multi-omics, and pragmatic post–TKI sequencing; concurrent regulatory momentum (zidesamtinib) signals tightening standards in driver-positive NSCLC. (read more)
  • Theme 1: Smarter IO Selection Beyond PD-L1
    • Significance: Multiple July abstracts and a living-guideline update push toward refined, cancer-type–specific predictors of immune checkpoint benefit rather than PD-L1 alone. (read more)
    • Mechanism insights / clinical impact: A tumor-intrinsic glycosylation program identifies an immune‑cold, ICB‑resistant NSCLC subset; the “IOSelect‑lung” model offers predictive value beyond current biomarkers. Smoking status modulated first‑line ICI effect sizes in Asian NSCLC, underscoring host–tumor context. Together, these data argue for integrating tumor biology and demographics into IO decisions. (read more)
    • Patient populations affected: Advanced NSCLC—particularly driver‑negative disease and Asian cohorts—where guideline‑driven IO choices and biomarker refinement may improve selection. (read more)
  • Theme 2: Liquid Biopsy and Multi‑Omics to Track Resistance and Minimal Residual Disease
    • Significance: July ASCO Breakthrough proceedings highlight ctRNA and integrated DNA/RNA approaches to illuminate resistance biology and support adaptive treatment; an Asia‑Pacific MRD consensus sets realistic guardrails for perioperative use. (read more)
    • Mechanism insights / clinical impact: ctRNA profiling and multi‑omics reveal evolving resistance and TME features; ATORG concludes MRD assays show high specificity/PPV but variable sensitivity—insufficient for routine adjuvant de‑escalation outside trials. Clinical takeaway: use ctDNA/ctRNA to monitor and learn, but avoid premature treatment de‑intensification. (read more)
    • Patient populations affected: Advanced NSCLC needing resistance surveillance and early‑stage resected NSCLC where MRD testing informs trials but should not yet drive de‑escalation. (read more)
  • Theme 3: Post–Targeted‑Therapy Sequencing and Driver‑Positive Expansion
    • Significance: Real‑world July analyses and an FDA action sharpen next‑step choices after TKI failure and expand options in ROS1‑positive disease. (read more)
    • Mechanism insights / clinical impact: After EGFR‑TKI resistance, carboplatin–pemetrexed–bevacizumab vs chemo‑IO comparisons inform regimen selection; first‑line ALK TKI safety differences may influence initial choice; zidesamtinib (Jideytro) adds a targeted second‑line for ROS1‑positive NSCLC after prior ROS1 inhibitor. (read more)
    • Patient populations affected: EGFR‑mutated (post‑TKI), ALK‑rearranged (frontline choice/safety), and ROS1‑positive (second‑line) NSCLC across global practice. (read more)
  • Significance
    • Expected clinical or translational readouts: Pre‑WCLC July coverage signals ongoing emphasis on frontline targeted strategies (e.g., KRAS G12C; exon 20), suggesting near‑term data maturation that could refine first‑line algorithms. (read more)
    • Regulatory or policy implications: July 22 FDA approval of zidesamtinib (Jideytro) in ROS1‑positive NSCLC and July 24 ASCO living‑guideline update (driver‑negative) will shape therapy selection and payer pathways. (read more)
    • Potential shifts in standard of care: Movement toward biomarker‑enhanced IO selection; clearer post‑EGFR‑TKI sequencing; standardized second‑line ROS1 targeted therapy. (ascopubs.org) (read more)
    • Strategic implications: Prioritize development/validation of glycosylation‑based and multi‑omics signatures; invest in ctRNA/MRD infrastructure with trial‑linked utility; differentiate portfolios via post‑TKI combinations and driver‑specific assets tuned to regional populations highlighted in July proceedings. (ascopubs.org) (read more)
Publications Related to Approved Drugs
Utilizing machine learning to identify multimodal signatures for patients who would benefit from the addition of tremelimumab to durvalumab and chemotherapy (TRIDENT). A post hoc analysis of the POSEIDON trial successfully used a machine learning model to identify genetic signatures (including KRAS and STK11 mutations) that predict which patients with non-squamous metastatic NSCLC derive the greatest overall survival benefit from adding tremelimumab to first-line durvalumab and chemotherapy. This approach highlights a potential strategy for enhancing precision in tailoring immunotherapy combinations for individual patients. ()
Efficacy of alectinib for ALK-positive NSCLC according to tumor burden and body mass index: A pooled analysis of the randomized phase III trials ALEX and J-ALEX. In a pooled analysis of the ALEX and J-ALEX trials, baseline tumor burden was identified as a significant prognostic and predictive factor for outcomes in ALK-positive NSCLC treated with alectinib versus crizotinib. The progression-free survival benefit of alectinib was more pronounced in patients with a low tumor burden, suggesting that patients with a high tumor burden may require treatment intensification. ()
Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Updated results from the IMscin001 and IMscin002 studies confirm that the subcutaneous administration of atezolizumab offers similar efficacy, safety, and immunogenicity compared to the intravenous formulation for patients with NSCLC. These findings support the use of the subcutaneous option, which is often preferred by patients and can reduce administration time, as switching between formulations was well tolerated. ()
New Publications Related to Drugs in Clinical Trial Development
PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials. The PROSPECT-Lung trial introduces a pragmatic phase III design for resectable NSCLC that dramatically simplifies protocol and data collection compared to traditional trials like Alliance A081801. This new model serves to improve clinical trial efficiency, reduce site burden, and enhance real-world relevance in evaluating perioperative versus adjuvant immunotherapy strategies. () .
High-dose furmonertinib as first-line treatment for untreated EGFR-mutated advanced NSCLC with central nervous system metastases: A phase 2 trial. This phase II trial shows that high-dose furmonertinib (160 mg daily) is a promising first-line treatment for untreated EGFR-mutated advanced NSCLC with CNS metastases. The agent demonstrated high intracranial (95.0%) and systemic (92.5%) objective response rates with a manageable safety profile. () .
First-Line Sacituzumab Govitecan Plus Pembrolizumab and Carboplatin in Metastatic Non-Small Cell Lung Cancer: Nonsquamous and Squamous Cohorts of the EVOKE-02 Study. The EVOKE-02 phase II study indicates that sacituzumab govitecan plus pembrolizumab and carboplatin shows promising activity in first-line metastatic NSCLC for both nonsquamous and squamous histologies. The combination had a tolerable safety profile at a reduced sacituzumab govitecan dose of 7.5 mg/kg, which was adjusted due to initial myelosuppression. () .
Datopotamab Deruxtecan Plus Pembrolizumab With or Without Platinum-Based Chemotherapy for Advanced or Metastatic NSCLC: The Phase Ib TROPION-Lung02 Trial. The phase Ib TROPION-Lung02 trial found that datopotamab deruxtecan (Dato-DXd) combined with pembrolizumab, with or without platinum chemotherapy, demonstrated durable antitumor activity and a manageable safety profile in patients with advanced or metastatic NSCLC. Notably, responses were observed across all programmed death-ligand 1 expression levels. () .
PARP inhibition combined with a T-cell receptor β chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression. Preclinical findings suggest that combining the PARP inhibitor olaparib with mSTAR1302 (murine surrogate of STAR0602), a selective T-cell agonist, induces significant tumor regression in immune-excluded prostate cancer models. This combination enhances polyclonal antitumor immunity, providing a strong rationale for clinical evaluation in metastatic castration-resistant prostate cancer. () .
BCL-2/BCL-xL inhibitor pelcitoclax with osimertinib for <i>EGFR</i>-mutated advanced non-small-cell lung cancer: a phase 1b trial. In a phase 1b trial, the combination of pelcitoclax and osimertinib showed a manageable safety profile and promising antitumor activity, particularly in TKI treatment-naïve patients with EGFR-mutated advanced NSCLC. This cohort achieved an 80.8% objective response rate and a median progression-free survival of 16.4 months. () .
The role of zongertinib, a highly selective tyrosine kinase inhibitor, in targeting <i>HER2</i>-mutant NSCLC: a bench-to-bedside review. Zongertinib, a highly selective oral HER2-TKI, has received accelerated approval based on the first-in-human Beamion LUNG-1 trial. The study demonstrated durable activity and a manageable safety profile in patients with previously treated advanced HER2-mutant NSCLC, establishing it as a new convenient and effective treatment option that spares wild-type EGFR. () .
Osimertinib Plus Gefitinib in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer and EGFR (C797X) Mutation Following First-Line Osimertinib: ORCHARD. The ORCHARD phase II study demonstrated that the combination of osimertinib and gefitinib provides modest clinical benefit for patients with EGFR-mutated advanced NSCLC who developed the C797X resistance mutation after first-line osimertinib. The regimen resulted in an objective response rate of 26% and a median progression-free survival of 5.1 months, indicating further evaluation is not warranted. () .
Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. The AENEAS2 phase 3 trial showed that first-line aumolertinib plus chemotherapy significantly improved progression-free survival (28.9 months) compared to aumolertinib monotherapy (18.9 months) in patients with EGFR-mutated advanced NSCLC. This establishes a new, more effective treatment option despite increased but manageable toxicity. () .
A phase II basket trial of DART SWOG S1609: the salivary gland tumor cohort. In the DART SWOG S1609 trial, the combination of ipilimumab and nivolumab showed limited efficacy in salivary gland tumors, with objective response rates of only 4% in adenoid cystic carcinoma and 9% in other histologies. These results suggest dual checkpoint inhibition is not a highly active strategy for this rare tumor type. () .
Bispecific Antibody Ivonescimab Added to Chemotherapy in EGFR-Variant Non-Small Cell Lung Cancer: The HARMONi-A Randomized Clinical Trial. The HARMONi-A phase 3 trial demonstrated that adding the bispecific antibody ivonescimab (targeting PD-1 and VEGF) to chemotherapy significantly improved overall survival (median 16.8 vs 14.1 months) for patients with EGFR-variant NSCLC who had progressed on prior TKI therapy. This finding offers a new, clinically meaningful treatment option for this patient population. () .
Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein Overexpressing, Nonsquamous, <i>EGFR</i> Wild-type Advanced NSCLC: Updated Analysis of the LUMINOSITY Trial. Updated analysis of the LUMINOSITY phase 2 trial confirms that telisotuzumab vedotin (Teliso-V) monotherapy provides durable responses in patients with previously treated, c-Met overexpressing, EGFR wild-type nonsquamous NSCLC. Efficacy was maintained irrespective of prior therapy type (platinum, immune checkpoint inhibitors, or both), and the agent had a manageable safety profile. () .
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 trials indicates that taletrectinib, a next-generation ROS1 TKI, offers superior response and survival outcomes over first-generation TKIs like crizotinib and entrectinib for TKI-naïve ROS1+ NSCLC patients. This supports taletrectinib as a highly effective first-line treatment option. () .
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. A phase 1b/2 study of the dual-oral, chemotherapy-free regimen of ifebemtinib (FAK inhibitor) plus garsorasib (KRASG12C inhibitor) showed an encouraging 82% objective response rate and a manageable safety profile as a first-line treatment for KRASG12C-mutated NSCLC. These findings have prompted a randomized phase 3 validation study. () .
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 trials 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. () .
Divergent Tumor Immune Microenvironment and Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-Small Cell Lung Cancer: A Single-Arm Phase II Trial. This phase II trial of neoadjuvant pembrolizumab plus chemotherapy in resectable NSCLC achieved a 37.5% major pathological response rate. Spatial profiling of tumors identified distinct immune phenotypes associated with response, suggesting a lymphoid-enriched signature could serve as a potential biomarker for adjuvant therapy benefit. () .
Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors. The first-in-human phase I study of Temab-A (ABBV-400), a novel c-Met antibody-drug conjugate with a topoisomerase 1 inhibitor payload, demonstrated a tolerable safety profile and promising antitumor activity in heavily pretreated metastatic colorectal cancer. The agent achieved an overall response rate of 15.6% and a median overall survival of 10.4 months. () .
CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. A pooled analysis of prospective trials shows that CT-guided intratumoral injection of immune checkpoint inhibitors or CAR-T cells is a safe approach for treating advanced solid tumors. This strategy resulted in a low rate of severe adverse events (8.88%) and a high disease control rate (95.27%), suggesting a viable method to mitigate systemic toxicity. () .
The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. Analysis of patients treated with the KRASG12C inhibitor glecirasib reveals that baseline and on-treatment circulating tumor cell (CTC) dynamics can predict survival and resistance. The levels of different CTC subtypes (epithelial vs. mesenchymal) correlated with progression-free and overall survival, highlighting CTCs as a valuable prognostic biomarker. () .
Izalontamab Brengitecan (Iza-Bren), a First-in-Class EGFR-HER3 Bispecific Antibody-Drug Conjugate in Extensive-Stage Small Cell Lung Cancer: Results From a Phase Ib Study. The phase Ib study of iza-bren, a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, demonstrated encouraging antitumor activity in relapsed extensive-stage SCLC. The treatment achieved a 48.1% overall response rate and showed particular promise in the second-line setting with a 72.7% ORR. () .
PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials. The PROSPECT-Lung trial introduces a pragmatic phase III design for resectable NSCLC that dramatically simplifies protocol and data collection compared to traditional trials like Alliance A081801. This new model serves to improve clinical trial efficiency, reduce site burden, and enhance real-world relevance in evaluating perioperative versus adjuvant immunotherapy strategies. () .
Safety and efficacy of fecal microbiota transplantation in solid cancers resistant to immune checkpoint inhibitors: results of the MITRIC trial. The MITRIC phase IIa trial found that fecal microbiota transplantation (FMT) combined with ICIs was safe and feasible for patients with advanced, ICI-refractory cancers. However, it showed limited clinical activity with no objective responses, though one melanoma patient achieved long-term stable disease of over 33 months. () .
Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Updated results from the IMscin001 and IMscin002 studies confirm that the subcutaneous formulation of atezolizumab has a similar efficacy, safety, and immunogenicity profile to the intravenous formulation in NSCLC patients. These findings support its use as a more convenient administration option that is preferred by patients. () .
Phase III Study of Niraparib Plus Pembrolizumab as Maintenance Therapy for Advanced or Metastatic NSCLC (ZEAL-1L). The ZEAL-1L phase 3 study concluded that adding the PARP inhibitor niraparib to pembrolizumab as maintenance therapy for advanced or metastatic NSCLC did not improve progression-free survival compared to pembrolizumab alone. The trial failed to meet its primary endpoint, showing no added benefit for the combination. () .
Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial. This phase 3 trial for unresectable stage III NSCLC found that adding nivolumab to CCRT, followed by consolidation with either nivolumab plus ipilimumab or nivolumab alone, did not improve progression-free or overall survival. The results were not superior to the standard of care (CCRT followed by durvalumab consolidation). () .
Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer. A phase 1 pharmacokinetic study and population modeling predict that a 300 mg subcutaneous thigh administration of tislelizumab every 3 weeks provides comparable drug exposure to the approved 200 mg intravenous dose. This supports its selection for phase 3 evaluation as a more convenient patient-centric option. () .
Early ctDNA Stratifies Survival in Locally Advanced and Oligometastatic Lung Cancer Treated with Radiotherapy. This prospective phase II trial demonstrates that a circulating tumor DNA (ctDNA) burden metric, ctFE, measured before and early during radiotherapy can strongly stratify survival outcomes for patients with locally advanced and oligometastatic NSCLC. This highlights its potential as a practical, noninvasive biomarker for risk stratification and treatment adaptation. () .
Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non-Small Cell Lung Cancer: Post Hoc Analysis of the Neotorch Randomized Clinical Trial. A post hoc analysis of the Neotorch phase 3 trial revealed that perioperative toripalimab plus chemotherapy in resectable stage III NSCLC led to significantly higher rates of tumor and lymph node downstaging compared to chemotherapy alone. This superior downstaging 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 2026-07-01 to 2026-07-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation--1---1
Not Yet Recruiting449-2120
Recruiting29222129-83
Available-------
Approved for Marketing-------
Active, Not Recruiting131425323-78
Completed121-3-7
Total4742575371189
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: Atezolizumab, Tretinoin NCT04919369 COMPLETED A Phase Ib Dose De-Escalation Study of All-Trans Retinoic Acid (ATRA) and Atezolizumab in Patients With Advanced Non-Small Cell Lung Cancer 2026-07-03
[14C]Zorifertinib Oral Formulation NCT07620951 RECRUITING Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China 2026-08
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 2026-08
Carboplatin, Gemcitabine, Nab-paclitaxel, Oxaliplatin, Sasanlimab, Paclitaxel, pemetrexed, Cisplatin, Leucovorin, PF-07934040, Pembrolizumab, Bevacizumab, Fluorouracil, Cetuximab 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
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Canakinumab, Durvalumab, Chemotherapy NCT04905316 COMPLETED Phase I/II Study of Canakinumab With Chemoradiation and Durvalumab for Unresected Locally-Advanced Non-Small Cell Lung Cancer (CHORUS) 2026-07-06
Tepotinib NCT02864992 ACTIVE_NOT_RECRUITING A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION) 2026-08-31
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Carboplatin, Retifanlimab, Pemetrexed, Paclitaxel, Cisplatin, nab-Paclitaxel, Placebo NCT04205812 COMPLETED A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304) 2026-05-28
Docetaxel, AMG 510 NCT04303780 COMPLETED 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 2026-06-24
4cycles(Placebo + platinum-based doublet chemotherapy)+13 cycles(Placebo ), 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab NCT04158440 COMPLETED A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer 2026-07-03
Cisplatin, SYS6010, Carboplatin, Pemetrexed NCT06927986 RECRUITING A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment 2026-08-30
Keytruda, SB27 NCT06348199 ACTIVE_NOT_RECRUITING A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer 2026-09
Gemcitabine, Cisplatin, : Pembrolizumab, Pemetrexed NCT03425643 ACTIVE_NOT_RECRUITING A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671) 2026-10-15
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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