Clinical Trials for Non-Small Cell Lung Cancer

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors (select cohorts: 2L+ cutaneous melanoma, EGFR-mutated or EGFR/ALK/ROS1–negative NSCLC, rare melanomas, other solid tumors; and in combination: 2L+ melanoma and HER2‑negative metastatic breast cancer) receive the HER3-targeting antibody–drug conjugate BNT326 (topoisomerase I payload) as monotherapy or combined with BNT327, a bispecific anti–PD-L1/anti–VEGF-A antibody. Includes a dedicated drug–drug interaction cohort with CYP inhibitors (itraconazole or paroxetine).

ClinicalTrials.gov ID: NCT07070232

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic EGFR-mutant NSCLC (ex19del/L858R), ECOG 0–1, after prior EGFR TKI; Part B requires C797X resistance mutation. Single‑agent DZD6008, an oral fourth‑generation, mutant‑selective EGFR TKI with designed activity against C797X (including C797S) and CNS penetration, is given once daily with dose escalation then expansion.

ClinicalTrials.gov ID: NCT06905197

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Single-arm study for adults with newly diagnosed advanced/metastatic NSCLC with PD-L1 ≥1% and no prior metastatic systemic therapy, testing intravenous trabedersen (OT-101)—an antisense oligonucleotide targeting TGF-β2 to reduce tumor immune suppression—combined with fixed-dose pembrolizumab. Phase 1 identifies the RP2D of OT-101 (4-days-on/10-days-off IV schedule) with pembrolizumab Q6W, followed by phase 2 assessing efficacy.

ClinicalTrials.gov ID: NCT06579196

MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with relapsed/refractory histiocytic neoplasms (including ECD, LCH, histiocytic sarcoma, Rosai-Dorfman) lacking actionable BRAF/MAP2K alterations or post–BRAF/MEK, plus high‑risk MDS/CMML/MF post‑standard therapy, and multiple relapsed/refractory lymphomas/CLL after ≥2 prior lines, receive oral Q702 (adrixetinib), a TAM kinase (AXL/MERTK) and CSF1R inhibitor given week-on/week-off. The trial assesses safety, RP2D, and preliminary efficacy across disease-specific cohorts.

ClinicalTrials.gov ID: NCT06712810

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with advanced/metastatic NSCLC harboring centrally confirmed NECTIN4 gene amplification (non-squamous and squamous cohorts), previously treated with up to 3 prior lines (including prior platinum/IO or appropriate targeted therapy for actionable drivers), receive zelenectide pevedotin (BT8009) monotherapy. BT8009 is a Nectin-4–targeted Bicycle Toxin Conjugate delivering MMAE; key exclusions include prior MMAE, active/untreated CNS mets, significant ocular disease, and active ILD/pneumonitis.

ClinicalTrials.gov ID: NCT06933329

A Phase II Trial of GT103 in Combination With Pembrolizumab in STK11 Mutant Non-Small Cell Lung Cancer (NSCLC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with advanced/metastatic STK11-mutant NSCLC who have progressed on a pembrolizumab-containing regimen yet are appropriate to continue pembrolizumab receive pembrolizumab plus GT103, a first-in-class anti–complement factor H (CFH) IgG3 monoclonal antibody that enhances complement activation and antitumor phagocytosis. Key exclusions include active/untreated brain mets and actionable oncogenic drivers (EGFR/ALK/ROS1/RET/MET/NTRK).

ClinicalTrials.gov ID: NCT07017829

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

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable advanced/metastatic solid tumors (excluding HCC, sarcomas, gliomas) who have progressed on or are unsuitable for standard therapy receive PRTH-101, an anti‑DDR1 monoclonal antibody intended to disrupt collagen-mediated T‑cell exclusion, either as monotherapy or combined with pembrolizumab. Suitable for ECOG 0–1 with treated/stable CNS disease only; key exclusions include active autoimmune disease on immunosuppression, uncontrolled infections, and recent systemic therapy or radiation.

ClinicalTrials.gov ID: NCT05753722

A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic NSCLC (squamous or non-squamous), including both first-line AGA-negative and previously treated patients (with genotype-specific prior therapy, e.g., post–third-gen EGFR TKI), receive the HER3-directed topoisomerase I ADC BNT326 combined with the PD-L1/VEGF-A bispecific antibody BNT327, with arms also testing each agent alone and standard-of-care comparators by PD-L1 status. Excludes prior HER3/topo I ADC exposure (with limited exceptions), uncontrolled ILD/pneumonitis, active CNS disease needing steroids/anticonvulsants, significant effusions, and high-grade prior irAEs leading to ICI discontinuation.

ClinicalTrials.gov ID: NCT07111520

A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic NSCLC (ECOG 0–1), excluding EGFR/ALK alterations, receive intratumoral tolododekin alfa (ANK-101), an anchored IL‑12 designed for localized immune activation, combined with an anti–PD-1/PD-L1 antibody. Includes two cohorts: post–PD-1/PD-L1 and platinum–pretreated patients receiving tolododekin alfa plus cetrelimab, and treatment‑naïve patients receiving tolododekin alfa plus investigator’s choice of approved PD-1/PD-L1 inhibitor; mandatory fresh biopsies.

ClinicalTrials.gov ID: NCT07027514