Clinical Trials for Non-Small Cell Lung Cancer

Phase Ib/II Study of Safety and Efficacy of EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of 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: Enrolling adults with advanced, measurable NSCLC (ECOG 0–1) with RECIST-confirmed progression within 12 weeks on prior anti–PD-1/PD-L1–based therapy (first- or second-line), excluding EGFR/ALK-altered disease and patients with uncontrolled CNS metastases or significant autoimmune/pneumonitis history. Patients receive oral tulmimetostat (investigational dual EZH2/EZH1 inhibitor that reduces H3K27me3 to re-express silenced genes and potentially re-sensitize tumors to immunotherapy) with a 7-day run-in, combined with pembrolizumab 200 mg IV q3wk for up to 2 years.

ClinicalTrials.gov ID: NCT05467748

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

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: Enrolling adults with advanced/metastatic nonsquamous NSCLC harboring KRAS G12C who have progressed after 1–2 prior lines including both PD-1/PD-L1 therapy and platinum chemotherapy, with no prior KRAS-targeted therapy and without active CNS disease or significant ILD/pneumonitis history. Patients are randomized to the investigational selective KRAS G12C-GDP covalent inhibitor MK-1084 combined with either patritumab deruxtecan (HER3-targeted topoisomerase I ADC), sacituzumab tirumotecan (TROP2-targeted topoisomerase I ADC), or cetuximab (EGFR monoclonal antibody).

ClinicalTrials.gov ID: NCT07286149

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types

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: Open-label multicohort study for patients with CLDN18.2-expressing unresectable locally advanced or metastatic gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or selected other solid tumors after at least one prior systemic therapy and ECOG 0–1. Participants receive IV ASP546C every 3 weeks, a CLDN18.2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload, with dose evaluation in gastroesophageal cancer and higher-dose cohorts in pancreatic and pan-tumor populations.

ClinicalTrials.gov ID: NCT07488676

A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours

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 ECOG 0–1 and advanced/metastatic unresectable solid tumors in selected cohorts: mesothelioma, metastatic pancreatic ductal adenocarcinoma, or KRAS G12C-mutated NSCLC. All receive investigational oral ODM-212, a pan-TEAD/Hippo pathway inhibitor targeting YAP/TAZ–TEAD signaling, combined respectively with ipilimumab/nivolumab, gemcitabine/nab-paclitaxel, or sotorasib.

ClinicalTrials.gov ID: NCT07563738

AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS 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: Open-label study for adults with previously untreated locally advanced unresectable or metastatic squamous or nonsquamous NSCLC without actionable driver alterations, ECOG 0–1, measurable disease, and available PD-L1 status; Part B requires PD-L1 TPS ≥1%. Patients receive IV PF-08634404, an investigational bispecific PD-1/VEGF antibody, in combination with another anticancer agent, including sigvotatug vedotin, an integrin β6–directed MMAE antibody-drug conjugate, in one cohort.

ClinicalTrials.gov ID: NCT07227298

A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

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 metastatic activating EGFR-mutant NSCLC progressing after prior third-generation EGFR TKI and platinum chemotherapy, or platinum-ineligible, receive ivonescimab, a bispecific PD-1/VEGF antibody, combined with either datopotamab deruxtecan, a TROP2-directed topoisomerase I ADC, or osimertinib. The study includes patients with ECOG 0–1 and measurable disease, allowing controlled/asymptomatic CNS disease.

ClinicalTrials.gov ID: NCT07535437

A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients 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 or metastatic solid tumors harboring specified RAS mutations, ECOG 0–1, generally without acceptable standard systemic options; a newly diagnosed pancreatic ductal adenocarcinoma cohort is also eligible. Patients receive oral ERAS-0015, a pan-RAS molecular glue that disrupts active RAS–effector interactions and inhibits MAPK signaling, alone or with other investigational anticancer agents.

ClinicalTrials.gov ID: NCT06983743

LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)

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.

TrialFetch AI summary: This trial targets adult patients with non-small cell and small cell lung cancers experiencing oligo-progression while on stable systemic therapy, assessing the addition of locally ablative therapies like stereotactic ablative radiotherapy (SABR) and interventional radiology ablation for up to five or fewer metastatic lesions.

ClinicalTrials.gov ID: NCT06103682

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

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.

TrialFetch AI summary: This trial investigates the safety and efficacy of [68Ga]Ga DOTA-5G for imaging and [177Lu]Lu DOTA-ABM-5G for treatment, targeting the integrin αvβ6, in up to 40 patients with metastatic non-small cell lung cancer who have progressed after previous treatments.

ClinicalTrials.gov ID: NCT06228482

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including 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.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adult patients with advanced solid tumors, including NSCLC, who have progressed after anti-PD-1/PD-L1 therapy to evaluate MEM-288, an oncolytic adenovirus with immunostimulatory properties, alone and in combination with the PD-1 inhibitor nivolumab.

ClinicalTrials.gov ID: NCT05076760