Clinical Trials for Non-Small Cell Lung Cancer

A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients with Advanced Cancer with and Without Pembrolizumab

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: Adults with advanced/metastatic solid tumors lacking standard options—including cohorts for pancreatic, gastric, NSCLC, colorectal, metastatic uveal melanoma (≤2 prior lines), PD‑1/L1–refractory cutaneous melanoma, and PD‑1/L1–relapsed solid tumors—receive oral LNS8801, a selective GPER agonist, as monotherapy or combined with pembrolizumab. Key exclusions include ERα‑positive malignancies, active CNS disease for combo, prior severe PD‑1/L1 irAEs (for combo), recent estrogen/ER‑directed therapy, and strong CYP modulators or PPIs.

ClinicalTrials.gov ID: NCT04130516

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

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: Adults with advanced/metastatic HER2-negative breast cancer (TNBC or HR+/HER2− post-CDK4/6 and chemo/ADC) or previously treated non-squamous NSCLC receive datopotamab deruxtecan (TROP2-directed ADC delivering a topoisomerase I inhibitor) plus prophylactic dexamethasone mouthwash. The study assesses whether short-course steroid mouthwash during the first three cycles reduces Dato-DXd–associated stomatitis while patients continue Dato-DXd q3w.

ClinicalTrials.gov ID: NCT06974604

DISCERN: Dual Immune Strategy Versus Single Checkpoint Inhibition Efficacy Response in PDL-1 Negative Non-Small Cell Lung Cancer (NSCLC)

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: Adults with stage IV, PD-L1–negative NSCLC without actionable drivers and detectable baseline ctDNA are randomized to standard chemo plus pembrolizumab versus chemo plus dual checkpoint blockade (nivolumab [PD-1] + ipilimumab [CTLA-4]), with maintenance per histology. Aims to assess early molecular response (ctDNA clearance by Cycle 4 Day 1) and key clinical outcomes; treated/stable CNS metastases allowed.

ClinicalTrials.gov ID: NCT06364917

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

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: Untreated adults with locally advanced unresectable or metastatic non-squamous NSCLC that overexpresses HER2 and has PD-L1 TPS &lt;50%, without actionable driver alterations or HER2 mutation. Randomized to trastuzumab deruxtecan (HER2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor) plus pembrolizumab versus standard pemetrexed/platinum plus pembrolizumab.

ClinicalTrials.gov ID: NCT06899126

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

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: Adults with locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424

LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients

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: Adults with previously treated stage IV NSCLC (ECOG 0–2) eligible for standard cytotoxic chemotherapy receive NCCN-concordant agents (e.g., docetaxel, paclitaxel, gemcitabine, pemetrexed, vinorelbine) selected by the investigational OncoChoice ex vivo drug-responsiveness assay performed on fresh tumor/fluid samples. Single-arm study assessing objective response, with secondary endpoints including 6-month PFS, OS, and QoL.

ClinicalTrials.gov ID: NCT06576635

PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition

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: Adults with advanced/metastatic clear cell renal cell carcinoma or non-small cell lung cancer who had at least stable disease on one prior line of PD-1/PD-L1 therapy but then radiographically progressed within 6 months of stopping it (ECOG 0–1; measurable disease; no active CNS disease or uncontrolled autoimmune disease) and lack/decline standard options. Patients receive retifanlimab (anti–PD-1 antibody) 500 mg IV every 4 weeks as checkpoint rechallenge combined with oral ruxolitinib (JAK1/2 inhibitor) twice daily with dose escalation to define the recommended dose.

ClinicalTrials.gov ID: NCT07219576

PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT

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: Enrolls adults with biopsy-proven NSCLC (excluding EGFR/ALK/ROS1/RET-altered tumors) or melanoma with radiographic liver metastases, ECOG 0–2, eligible for standard PD-1/PD-L1 checkpoint inhibitor–based therapy (± chemotherapy and/or CTLA-4 inhibition per routine practice). All patients receive standard systemic therapy plus investigational low-dose liver radiation delivered in the week before cycles 1, 2, and 3 to potentially modulate the hepatic immune microenvironment and enhance checkpoint inhibitor efficacy.

ClinicalTrials.gov ID: NCT07225036

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory 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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 locally advanced or metastatic NSCLC (ECOG 0–1) with RECIST-measurable disease who have progressed on prior anti–PD-(L)1 therapy and have no remaining/acceptable standard metastatic options (treated stable brain metastases allowed) receive SAR445877 IV every 2 weeks. SAR445877 is a bifunctional fusion protein providing PD-1 blockade with targeted IL-15 pathway stimulation to expand/activate CD8+ T cells and NK cells, with mandatory repeat biopsies for biomarker studies.

ClinicalTrials.gov ID: NCT07133425

Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic Non-Small-Cell Lung Cancer

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: Adults with stage IV NSCLC without actionable driver mutations (ECOG 0–2) who develop oligoprogression (≤5 lesions, all safely treatable with SBRT/ablative RT) after ≥3 cycles of first-line immune checkpoint inhibitor–based therapy (ICI alone or ICI+chemotherapy; stable treated CNS metastases allowed). Compares SBRT/ablative radiotherapy to all progressing sites with continuation of current standard systemic management versus no RT and switching to standard approved second-line systemic therapy.

ClinicalTrials.gov ID: NCT06686771