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
- Trial result
Non-small cell lung cancer
Encorafenib + binimetinib (BRAF/MEK inhibition) validates FoundationOne Liquid/Tissue CDx for BRAF V600E NSCLC selection
FoundationOne®Liquid CDx (F1LCDx; plasma ctDNA) and FoundationOne®CDx (F1CDx; tissue) are FDA-approved companion diagnostics for identifying BRAF V600E–mutant metastatic NSCLC patients eligible for encorafenib…
NCT03915951 - Trial result
Non-small cell lung cancer
Baseline PPIs correlate with sharply worse durvalumab outcomes in PACIFIC
Durvalumab is a PD-L1 antibody used as 12-month consolidation after concurrent chemoradiotherapy in unresectable stage III NSCLC. In a post-hoc analysis of PACIFIC treated patients consenting to exploratory analyses…
- New trial
Non-small cell lung cancer
Phase 2 cemiplimab PD-1 inhibitor plus platinum doublet chemo as neoadjuvant therapy in stage I NSCLC.
This Medical University of South Carolina (MUSC) investigator-initiated Phase 2 study tests whether adding cemiplimab (Libtayo; Regeneron Pharmaceuticals + Sanofi), a PD-1 (CD279)–blocking monoclonal antibody that…
NCT07720167 Exploratory - Trial result Spotlight
Non-small cell lung cancer
Selpercatinib (RET inhibitor) slashes recurrence risk in resected RET fusion+ NSCLC (2-year EFS 92% vs 61%)
Selpercatinib is an oral, highly selective RET tyrosine kinase inhibitor (CNS-penetrant) tested as adjuvant targeted therapy in the Phase 3, double-blind LIBRETTO-432 trial (NCT04819100) in RET fusion–positive stage…
NCT04819100 - Trial result Spotlight
Non-small cell lung cancer
Sunvozertinib (EGFR exon20ins TKI) extends PFS vs carbo/pem chemo in 1L EGFR exon20ins NSCLC (WU-KONG28)
Sunvozertinib is an oral EGFR tyrosine kinase inhibitor designed to inhibit EGFR exon 20 insertion mutations, tested head-to-head vs platinum doublet in the confirmatory multinational Phase 3 WU-KONG28 trial…
NCT05668988 - Trial result
Non-small cell lung cancer
Nivolumab (PD-1 inhibitor) Fails to Improve DFS vs Observation After NSCLC Resection
Nivolumab is an anti–PD-1 checkpoint inhibitor tested as *adjuvant* therapy after upfront surgery (and after completion of planned adjuvant chemotherapy and/or radiotherapy) in the ECOG-ACRIN EA5142 Phase 3 trial…
NCT02595944 - Trial result
Non-small cell lung cancer
Silevertinib (BDTX-1535), a covalent 4th-gen EGFR TKI, drives 60% ORR and 86% CNS responses in 1L non-classical EGFR NSCLC
Silevertinib (BDTX-1535) is a fourth-generation, covalent EGFR tyrosine kinase inhibitor designed to cover non-classical EGFR mutations (including P-loop/αC-helix–compressing [PACC] variants) with high CNS…
NCT05256290 - New trial Spotlight
Non-small cell lung cancer
Phase 3 CAN-2409 HSV-tk adenoviral gene therapy + prodrug with PD-1 blockade in NSCLC
Candel Therapeutics’ Phase 3 AURORA trial randomizes patients 1:1 to either intratumoral aglatimagene besadenovec (CAN-2409)—a replication-deficient adenoviral vector delivering the HSV-tk “suicide gene”—plus oral…
NCT07660094 Registrational - New trial
Non-small cell lung cancer
Phase 3 Atezolizumab PD-L1 inhibitor (± hyaluronidase for SC delivery) after Stage I NSCLC resection
National Cancer Institute (NCI) is running AASI-NSCLC, a randomized Phase 3 adjuvant study testing whether 1 year of anti–PD-L1 immunotherapy reduces recurrence after complete (R0) surgery for Stage IA3 or IB NSCLC…
NCT07388524 Registrational - New trial Spotlight
Non-small cell lung cancer
Phase 3 setidegrasib (ASP3082) KRAS G12D–targeted protein degrader vs docetaxel
Astellas Pharma Global Development is running this randomized, open-label Phase 3 study comparing setidegrasib (ASP3082) with docetaxel in adults with locally advanced unresectable or metastatic NSCLC harboring KRAS…
NCT07566052 Registrational - New trial
Non-small cell lung cancer
Phase 2 olomorasib KRAS G12C covalent inhibitor + pembrolizumab PD‑1 blockade in 1L NSCLC.
This UNC Lineberger Comprehensive Cancer Center study (NCT07639242) tests first-line olomorasib plus pembrolizumab in locally advanced/metastatic NSCLC with a KRAS G12C mutation and PD-L1 TPS 1–49%. Olomorasib (Eli…
NCT07639242 Exploratory - New trial
Non-small cell lung cancer
Phase 2 PF-08634404 trial tests PD-1×VEGF bispecific antibody in stage II–III NSCLC
This open-label Phase 2 Pfizer study (NCT07489066) evaluates PF-08634404—an investigational bispecific antibody that targets PD-1 (to relieve T-cell inhibition) and VEGF/VEGF-A (to reduce pro-angiogenic,…
NCT07489066 Exploratory - New trial Spotlight
Non-small cell lung cancer
Phase 3 calderasib (MK-1084) KRAS G12C inhibitor + durvalumab PD-L1 antibody after CCRT
Merck Sharp & Dohme (Merck/MSD) is running KANDLELIT-015 (MK-1084-015), a Phase 3 randomized, triple-blind, parallel-group trial in unresected stage II (node-positive) to stage III, predominantly nonsquamous NSCLC…
NCT07554339 Registrational - New trial
Non-small cell lung cancer
Phase 1 64Cu-DOTA-pembrolizumab PET radiotracer targets PD-1 to guide SBRT decisions
City of Hope is running this Phase 1 pilot to test safety, feasibility, and imaging performance of 64Cu‑DOTA‑pembrolizumab (64CDP)—a PET radiotracer made by chelating copper‑64 to pembrolizumab (Merck/MSD’s…
NCT07619599 Exploratory - New trial
Non-small cell lung cancer
Phase 1 tepotinib + ivonescimab trial tests MET inhibitor plus PD-1×VEGF bispecific.
Memorial Sloan Kettering Cancer Center is running this Phase 1 pilot to establish a tolerable and preliminarily active combination of tepotinib (a small-molecule MET/c-Met/HGFR tyrosine kinase inhibitor; Merck…
NCT07619339 Exploratory - Trial result Spotlight
Non-small cell lung cancer
Sevabertinib (HER2 TKI) sustains 67–75% ORR in HER2-mutant NSCLC with no ILD signal
Sevabertinib is a potent, reversible, oral HER2 (ERBB2) tyrosine kinase inhibitor evaluated at 20mg BID in the open-label Phase I/II SOHO-01 trial (NCT05099172) in advanced HER2–tyrosine kinase domain–mutant NSCLC…
NCT05099172 - Trial result Spotlight
Non-small cell lung cancer
Neladalkib (next-gen ALK TKI; TRK-sparing) posts 31% ORR post–multiple ALK TKIs, with 68% ORR in G1202R ALK+ NSCLC
Neladalkib is an investigational, brain-penetrant ALK tyrosine kinase inhibitor designed to cover single/compound ALK resistance mutations (including G1202R) while sparing TRK, evaluated in the global single-arm…
NCT05384626 - Trial result Spotlight
Non-small cell lung cancer
Lunbotinib (A400/EP0031) selective RET inhibitor posts 81–87% ORR and 27.5-mo mPFS in RET-fusion NSCLC
Lunbotinib is an oral, brain-penetrant next-generation selective RET inhibitor designed to inhibit RET fusion and mutant proteins, evaluated in a pivotal Phase II, two-cohort, single-arm study in China (NCT05265091)…
NCT05265091 - Trial result Spotlight
Non-small cell lung cancer
Divarasib (KRAS G12C inhibitor) + pembrolizumab drives 73% ORR and 19.3-mo PFS in 1L KRAS G12C+ NSCLC
Divarasib is an oral, next-generation covalent KRAS G12C inhibitor combined with pembrolizumab (PD-1) in the open-label Phase Ib/II Krascendo-170 dose-finding/expansion study (NCT05789082) in untreated…
NCT05789082 - Trial result Spotlight
Non-small cell lung cancer
BH-30643 (OMNI‑EGFR mutant‑selective macrocyclic TKI) shows 59% ORR in post‑osimertinib C797S NSCLC (incl CNS)
BH-30643 is a first-in-class macrocyclic, non-covalent “OMNI‑EGFR” inhibitor engineered to selectively hit EGFR driver mutations while largely sparing WT EGFR and retaining activity against C797S with or without…
NCT06706076 - Trial result Spotlight
Non-small cell lung cancer
SSGJ-707 (PF-08634404) PD-1×VEGF Bispecific Delivers 67.6% ORR and 12.4-mo mPFS in 1L PD-L1+ NSCLC
SSGJ-707 is a fully human IgG4 bispecific antibody that simultaneously binds PD-1 and VEGF, aiming to pair checkpoint blockade with anti-angiogenic activity in a single agent. In the Phase 2 NCT06361927 dose-finding…
NCT06361927 - Trial result Spotlight
Non-small cell lung cancer
Lattice SF-SBRT + Toripalimab/Chemo Drives 95% MPR in Resectable NSCLC
Lattice spatially fractionated SBRT delivers a single preoperative radiation fraction with a 12 Gy peak and <4 Gy valley, here combined with toripalimab, a PD-1 antibody, plus platinum-doublet chemotherapy in a…
NCT06293690 - Trial result
Non-small cell lung cancer
FLARE-RT PET/SPECT-guided risk-adaptive RT boosts durability of locoregional control in unresectable NSCLC
FLARE-RT (Phase II; NCT02773238) tested biological image-guided chemoradiation for AJCCv7 stage IIB–IIIB unresectable NSCLC (n=49), combining functional lung avoidance (SPECT/CT) with mid-treatment FDG-PET response…
NCT02773238 - Trial result
Non-small cell lung cancer
Pembrolizumab (PD-1) + platinum doublet chemo shows larger OS benefit after crossover adjustment in 1L metastatic NSCLC
Pembrolizumab is an anti–PD-1 monoclonal antibody; here, pooled 5-year follow-up datasets from Phase 3 KEYNOTE-189 (nonsquamous; n=646 across global + Japan extension) and KEYNOTE-407 (squamous; n=669 across global +…
- Trial result
Non-small cell lung cancer
Nivolumab (PD-1) adjuvant therapy fails to extend DFS after NSCLC resection + chemo (EA5142/ALCHEMIST)
Nivolumab is an anti–PD-1 checkpoint inhibitor tested as 1 year of adjuvant therapy (480 mg IV q4w) after surgery and completion of standard adjuvant chemotherapy and/or PORT in resected high-risk NSCLC (tumor ≥4cm…
NCT02595944 - Trial result
Non-small cell lung cancer
Adjuvant erlotinib (EGFR TKI) fails to improve OS after resection in EGFR-mutant NSCLC
Erlotinib is a first-generation oral EGFR tyrosine kinase inhibitor (exon19 del/L858R) tested in the ALCHEMIST/Alliance A081105 randomized Phase 3 adjuvant trial (NCT02193282) in completely resected stage IB (≥4cm),…
NCT02193282 - Trial result
Non-small cell lung cancer
Pembrolizumab + lenvatinib (VEGFR/FGFR TKI) hits biomarker-gated ORR in 1L NSCLC, but survival looks broadly similar across groups
Pembrolizumab (anti–PD-1) was combined with lenvatinib (multi-kinase VEGFR/FGFR inhibitor), quavonlimab (CTLA-4 mAb), or favezelimab (LAG-3 mAb) in the biomarker-directed, adaptively randomized Phase 2…
NCT03516981 - Trial result
Non-small cell lung cancer
Nogapendekin alfa inbakicept (NAI; IL-15R agonist) boosts PFS/OS signals when added to 1L PD-1–based SOC in metastatic NSCLC
Nogapendekin alfa inbakicept (NAI) is an IL-15 receptor agonist designed to expand NK cells and effector/memory T cells and sustain absolute lymphocyte counts (ALC), aiming to preserve “immune competence” during…
NCT03520686 - Trial result
Non-small cell lung cancer
Durvalumab (anti–PD-L1) reshapes the TME and deepens EFS benefit in resectable NSCLC (AEGEAN)
Durvalumab is a PD-L1–blocking antibody given perioperatively with platinum-based neoadjuvant chemotherapy (4 cycles Q3W) then adjuvantly (12 cycles Q4W) in the Phase 3, double-blind AEGEAN trial (NCT03800134) in…
NCT03800134 - Trial result
Non-small cell lung cancer
Pralsetinib (RET TKI) doubles PFS vs platinum SOC in 1L RET+ metastatic NSCLC—but infections jump
Pralsetinib is an oral, selective RET tyrosine kinase inhibitor evaluated in AcceleRET-Lung, a randomized, open-label Phase 3 trial in previously untreated RET fusion–positive advanced/metastatic NSCLC (NCT04222972).…
NCT04222972
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