Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in non-small cell lung cancer
- New trial Spotlight
Non-small cell lung cancer
Phase 2/3 EIK1001 TLR7/8 agonist + pembrolizumab chemo in 1L stage 4 NSCLC
This global, multicenter, randomized, double-blind, placebo-controlled adaptive Phase 2/3 trial (TeLuRide-008) tests whether adding Eikon Therapeutics’ EIK1001—an IV Toll-like receptor 7/8 (TLR7/8) innate immune…
NCT07365319 Exploratory - New trial
Non-small cell lung cancer
Phase 2 nivolumab PD‑1 inhibitor + hypofractionated ablative RT vs docetaxel chemo
University of Chicago is running a randomized Phase 2 study testing whether adding hypofractionated ablative external-beam radiotherapy (EBRT) to continued immune checkpoint inhibition can improve outcomes in…
NCT07603856 Exploratory - New trial
Non-small cell lung cancer
Phase 2 ivonescimab PD-1×VEGF bispecific antibody consolidation after SBRT in early NSCLC
Memorial Sloan Kettering Cancer Center is running I-PRECISE, a Phase 2 study asking whether adding ivonescimab after definitive stereotactic body radiotherapy (SBRT)—delivered with either photon or proton…
NCT07594522 Exploratory - Trial result Spotlight
Non-small cell lung cancer
CJRB-101 (live Leuconostoc mesenteroides biotherapeutic) + PD-1 blockade drives 58% ORR in PD-L1-high 1L metastatic NSCLC
CJRB-101 is an oral live biotherapeutic product (novel *Leuconostoc mesenteroides* strain) designed to remodel the gut microbiome/tumor microenvironment and was combined with pembrolizumab (anti–PD-1) in a…
NCT05877430 - New trial Spotlight
Non-small cell lung cancer
Phase 1/2 navlimetostat PRMT5 inhibitor + pumitamig PD-L1×VEGF-A bispecific in MTAP-loss NSCLC.
This MD Anderson–sponsored Phase 1/2 study tests navlimetostat (aka MRTX1719/BMS-986504), an MTA-cooperative PRMT5 inhibitor designed to preferentially suppress PRMT5 activity in MTAP-deleted tumors, combined with…
NCT07579221 Exploratory - Trial result
Non-small cell lung cancer
Amivantamab (EGFR–MET bispecific) delivers 32% ORR in METex14 NSCLC—including 19% post–MET TKI
Amivantamab is an intravenous EGFR–MET bispecific antibody with immune cell–directing activity evaluated in the CHRYSALIS trial in advanced MET exon 14 skipping (METex14) NSCLC after progression on or refusal of…
- Trial result
Non-small cell lung cancer
Lazertinib (3rd-gen EGFR TKI) matches osimertinib in 1L EGFR-mutant NSCLC—no PFS advantage in MARIPOSA
Lazertinib is a CNS-penetrant, third-generation EGFR tyrosine kinase inhibitor (TKI) engineered for mutant EGFR selectivity (and chosen for combination with the EGFR-MET bispecific antibody amivantamab partly due to…
- Trial result
Non-small cell lung cancer
Cemiplimab (PD-1) monotherapy doubles OS vs chemo in PD-L1≥50% 1L NSCLC at 5 years
Cemiplimab is an anti–PD-1 checkpoint inhibitor given as monotherapy for up to 2 years; EMPOWER-Lung 1 was a randomized Phase 3 trial comparing cemiplimab 350mg IV Q3W vs investigator’s-choice platinum-doublet…
- Trial result Spotlight
Non-small cell lung cancer
THIO (telomere-targeting nucleoside analog) → sequential cemiplimab (PD-1) posts 16.9-mo OS signal in 3L ICI-resistant NSCLC
THIO is a first-in-class telomere-targeting agent designed to disrupt telomere integrity in telomerase-positive tumor cells and was sequenced before cemiplimab (a PD-1 antibody) in the multicenter, open-label Phase 2…
NCT05208944 - Trial result
Non-small cell lung cancer
ctFE (tumor-naïve ctDNA burden metric) predicts OS/PFS early during chemoRT for LA/oligometastatic NSCLC
In the prospective Phase II NCT03916419 trial, circulating tumor fraction estimate (ctFE)—a machine learning-derived composite of ctDNA burden from a clinically available, tumor-naïve assay—was measured at baseline…
NCT03916419 - Trial result
Non-small cell lung cancer
Amivantamab (EGFR/MET bispecific) + Lazertinib (EGFR TKI) Suppresses MET/EGFR Resistance vs Osimertinib, Extends 2L PFS
Amivantamab is an IV bispecific antibody targeting EGFR and MET, combined here with lazertinib, a 3rd-gen EGFR tyrosine kinase inhibitor; this MARIPOSA (Phase 3; NCT04487080) brief report used paired baseline/EOT…
NCT04487080 - Trial result
Non-small cell lung cancer
Tiragolumab (anti‑TIGIT) + atezolizumab (PD‑L1) + chemo misses PFS/OS vs pembrolizumab‑chemo in 1L nonsquamous NSCLC
SKYSCRAPER‑06 (Phase 3; NCT04619797) randomized previously untreated, locally advanced unresectable/metastatic nonsquamous NSCLC without EGFR/ALK alterations to tiragolumab (anti‑TIGIT) + atezolizumab (anti‑PD‑L1) +…
NCT04619797 - Trial result Spotlight
Non-small cell lung cancer
Taletrectinib (CNS-penetrant ROS1 TKI) posts ~90% ORR and ~46-mo mPFS in ROS1+ NSCLC first-line
Taletrectinib is an oral, next-generation, selective ROS1 tyrosine kinase inhibitor (TKI) with CNS activity; this pooled update of the single-arm Phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials…
NCT04395677 - New trial
Non-small cell lung cancer
Phase 1/2 ANS02 trial tests a 4th‑generation EGFR tyrosine kinase inhibitor.
This first-in-human, open-label, multicenter Phase 1/2 study evaluates ANS02 monotherapy in adults with locally advanced or metastatic EGFR mutation–positive non-small cell lung cancer (NSCLC), focusing on…
NCT07538804 First-in-human - New trial
Non-small cell lung cancer
Phase 2 CIMAvax‑EGF anti‑EGF vaccine plus KRAS G12C inhibitors in metastatic NSCLC
Roswell Park Comprehensive Cancer Center is running this Phase 2, open-label combination study testing whether adding CIMAvax‑EGF to an approved KRAS G12C inhibitor can improve disease control in advanced/metastatic…
NCT07543172 Exploratory - New trial
Non-small cell lung cancer
Phase 2 ateganosine (THIO) telomere-targeting nucleoside sequenced with PD-1 inhibitor cemiplimab
MAIA Biotechnology’s multicenter, open-label Phase 2 THIO-101 study tests whether ateganosine (THIO; 6‑thio‑2′‑deoxyguanosine), a telomere-targeting small-molecule nucleoside, can re-sensitize…
NCT05208944 Exploratory - Trial result Spotlight
Non-small cell lung cancer
Zongertinib (HER2-selective irreversible TKI) hits 76% ORR and 14.4-mo PFS as 1L HER2-mutant NSCLC option
Zongertinib is an oral, irreversible HER2 (ERBB2) tyrosine kinase inhibitor designed to spare wild-type EGFR, evaluated in the Phase 1a/1b Beamion LUNG-1 multicohort trial (NCT04886804) at 120mg QD in previously…
NCT04886804 - Trial result Spotlight
Non-small cell lung cancer
Risvutatug rezetecan (B7-H3 TOP1i ADC) + adebrelimab (PD-L1) posts 47% cORR and 11.2-mo mPFS in 2L+ nsq-NSCLC
Risvutatug rezetecan (Ris-Rez; HS-20093/GSK5764227) is a B7-H3–targeted antibody-drug conjugate delivering a topoisomerase-1 inhibitor payload, combined here with adebrelimab, an anti–PD-L1 monoclonal antibody, in…
NCT06332170 - Trial result
Non-small cell lung cancer
Taletrectinib (CNS-penetrant ROS1 TKI) delivers 55.8% ORR and 9.7-mo mPFS after prior ROS1 TKI
Taletrectinib (Ibtrozi) is an oral, next-generation, CNS-active, selective ROS1 tyrosine kinase inhibitor evaluated in pooled Phase 2 TRUST-I (NCT04395677; prior crizotinib) and TRUST-II (NCT04919811; prior…
NCT04395677 - Trial result
Non-small cell lung cancer
Daraxonrasib (RMC-6236) RAS(ON) tri-complex inhibitor moves to Phase 3 vs docetaxel in RAS-mutant NSCLC
Daraxonrasib is an oral, RAS(ON) multi-selective tri-complex inhibitor designed to bind GTP-bound mutant and wild-type RAS, and is being advanced into RASolve 301, a global, open-label, randomized Phase 3 trial…
NCT06881784 - Trial result
Non-small cell lung cancer
IPH5201 (anti-CD39) + durvalumab (PD-L1) + platinum chemo posts 27.5% pCR in resectable NSCLC—signal enriches to 50% in PD-L1≥50%
IPH5201 is a blocking anti-CD39 monoclonal antibody (reduces adenosine generation by inhibiting CD39-mediated ATP breakdown) combined with durvalumab (anti–PD-L1) on top of neoadjuvant platinum-based chemotherapy in…
NCT05742607 - Trial result
Non-small cell lung cancer
ANS03 (type II ROS1/TRK TKI) shows 54.5% ORR in heavily pretreated ROS1+ NSCLC, including L2086F activity
ANS03 is a next-generation oral type II tyrosine kinase inhibitor targeting ROS1 and TRK designed to cover key acquired resistance mutations (including solvent-front mutations and the ROS1 Cβ6 L2086F). In the ongoing…
NCT06716138 - New trial Spotlight
Non-small cell lung cancer
Phase 1/2 ivonescimab PD-1×VEGF-A bispecific with Dato-DXd TROP2 ADC or osimertinib EGFR TKI
MSK is running a non-randomized, open-label Phase 1/2 trial in metastatic EGFR-activating–mutant NSCLC after prior EGFR TKI therapy, testing a fixed dose of ivonescimab (a PD-1 and VEGF-A–targeted bispecific…
NCT07535437 Exploratory - New trial
Non-small cell lung cancer
Phase 1/2 ivonescimab PD-1×VEGF-A bispecific antibody with platinum chemo + SRS in NSCLC brain mets.
This Memorial Sloan Kettering–sponsored Phase 1/2 study tests ivonescimab (AK112/SMT112)—a tetravalent bispecific antibody that blocks PD-1 on T cells and neutralizes VEGF-A to combine immune checkpoint inhibition…
NCT07535463 Exploratory - Trial result Spotlight
Non-small cell lung cancer
Trastuzumab Deruxtecan (HER2 ADC) posts 50–56% ORR in HER2-mutant mNSCLC
Trastuzumab deruxtecan (T-DXd) is a HER2-targeted antibody–drug conjugate with a topoisomerase-I payload; in the dose-blinded, randomized Phase 2 DESTINY-Lung02 (NCT04644237), previously treated HER2-mutant mNSCLC…
NCT04644237 - New trial Spotlight
Non-small cell lung cancer
Phase II randomized: durvalumab + monalizumab (NKG2A) vs durva + oleclumab (CD73) → RT in PD-L1-high, unresectable stage III
Montefiore compares two chemo-free “priming” pairs (AstraZeneca and Innate Pharma) prior to risk-adapted radiotherapy in treatment-naïve stage III (PD-L1 ≥50%). PACIFIC established durvalumab after chemoradiation;…
NCT07146230 Exploratory - New trial
Non-small cell lung cancer
Phase 2 SAR445877 PD-1/IL-15 fusion protein immunotherapy for NSCLC
This Phase 2 biomarker study at MD Anderson Cancer Center evaluates SAR445877, an investigational immunotherapy from Sanofi (acquired with Kadmon in 2021) that combines a PD-1 antibody fused with a safer version of…
NCT07133425 Exploratory - Trial result Spotlight
Non-small cell lung cancer
CT-P16 (bevacizumab biosimilar, anti-VEGF) matches reference bevacizumab in nsNSCLC
From a South Korean biopharma company, Celltrion’s CT-P16 is a bevacizumab biosimilar (anti-VEGF-A mAb). In a randomized, double-blind, global, multicenter Phase 3 first-line study for metastatic/recurrent…
NCT03676192 - Trial result
Non-small cell lung cancer
Sotorasib (KRAS G12C) Improves CNS PFS vs Docetaxel in Pretreated NSCLC
CodeBreaK 200 (phase 3; global; NCT04303780) randomized previously treated KRAS G12C-mutated advanced NSCLC (~10–13% of non-squamous NSCLC) to Amgen's sotorasib 960 mg daily vs docetaxel 75 mg/m² q3w; this…
NCT04303780 - Trial result
Non-small cell lung cancer
BL-B01D1 (EGFR×HER3 ADC) cORR 54–67% in Exon20/HER2-Mutant NSCLC
Iza-bren (BL-B01D1) is an EGFR×HER3 bispecific ADC carrying a topo-I payload (Ed-04) via a tetrapeptide cleavable linker; in a phase Ib expansion (NCT05194982), adults with advanced NSCLC harboring pre-specified…
NCT05194982
Looking for trials that fit a specific diagnosis? Read our guide on how to find a clinical trial, or subscribe to New in Oncology to get each issue by email.