Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

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 adults and adolescents with advanced or metastatic solid tumors (including NSCLC) harboring ALK, ROS1, or NTRK1-3 gene rearrangements to receive repotrectinib, a next-generation oral tyrosine kinase inhibitor designed to overcome resistance mutations in these oncogenic fusions. Eligible patients may have received prior TKIs and may have asymptomatic CNS metastases.

ClinicalTrials.gov ID: NCT03093116

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

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: Eligible patients are adults with advanced or metastatic solid tumors—including urothelial, triple negative breast, non-small cell lung, esophageal, pancreatic, ovarian, cervical (squamous), head and neck squamous cell, and prostate cancers—who have exhausted standard therapies and have ECOG 0–1. All participants receive intravenous LY4101174, a novel antibody-drug conjugate targeting nectin-4 and delivering a topoisomerase I inhibitor (exatecan).

ClinicalTrials.gov ID: NCT06238479

A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen

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 metastatic or unresectable non-small cell lung cancer refractory to standard therapies, good performance status, and resectable tumor for TIL harvest receive adoptive transfer of autologous "young" tumor-infiltrating lymphocytes following non-myeloablative cyclophosphamide/fludarabine, then either high- or low-dose aldesleukin (IL-2) for immune support. This personalized cellular immunotherapy aims to induce tumor regression by reinfusing ex vivo-expanded lymphocytes reactive to patient-specific tumor antigens.

ClinicalTrials.gov ID: NCT02133196

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

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: Eligible patients are adults with locally advanced or metastatic non-small cell lung cancer harboring a KRAS G12C mutation and good performance status. The study is evaluating BBO-8520, a first-in-class dual ON/OFF KRAS G12C inhibitor, as monotherapy and in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT06343402

Phase 1/2 Study of TSN1611 in Subjects with Advanced Solid Tumors Harboring KRAS G12D Mutation

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: Eligible patients are adults with locally advanced or metastatic solid tumors harboring a KRAS G12D mutation, who have progressed on or are intolerant to standard therapies and meet organ function and performance status criteria. The investigational drug TSN1611, an oral small molecule inhibitor targeting both active and inactive forms of KRAS G12D, is administered as monotherapy.

ClinicalTrials.gov ID: NCT06385925

A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors

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: This trial enrolls adults with unresectable or metastatic solid tumors (including NSCLC, high-grade serous ovarian carcinoma, and uterine serous carcinoma), ECOG 0-1, and at least one accessible lesion for biopsy. Patients receive BMS-986463, a novel investigational antineoplastic agent with an undisclosed mechanism of action, as monotherapy.

ClinicalTrials.gov ID: NCT06476808

First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

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: This trial enrolls adults with locally advanced or metastatic NSCLC harboring EGFR (and in some cohorts, HER2) exon 20 insertion mutations who have received prior therapy, treating them with STX-721, an investigational oral irreversible tyrosine kinase inhibitor that selectively targets mutant EGFR and HER2.

ClinicalTrials.gov ID: NCT06043817

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

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 advanced solid tumors and good performance status are eligible for this study of BMS-986507, a bispecific EGFR/HER3-targeting antibody-drug conjugate with a topoisomerase I inhibitor payload, in combination with either osimertinib or pembrolizumab. Key exclusions include untreated symptomatic CNS metastases, mixed SCLC/NSCLC, and severe infection or cardiac disease.

ClinicalTrials.gov ID: NCT06618287

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

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: Adult patients with advanced or metastatic solid tumors harboring a KRAS G12D mutation (including pancreatic, colorectal, or NSCLC), ECOG 0-1, and no prior KRAS G12D inhibitor exposure are eligible for treatment with INCB161734, a selective oral KRAS G12D inhibitor, given alone or in combination with standard therapies (e.g., gemcitabine/nab-paclitaxel, mFOLFIRINOX, cetuximab, or retifanlimab).

ClinicalTrials.gov ID: NCT06179160

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

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: This trial enrolls adults with advanced or metastatic solid tumors (including IDH-wildtype glioblastoma) harboring MTAP loss who have progressed on standard therapy, and tests TNG456, a selective, brain-penetrant PRMT5 inhibitor, as monotherapy or in combination with abemaciclib (CDK4/6 inhibitor). Eligible patients must have measurable disease, good performance status, and adequate organ function.

ClinicalTrials.gov ID: NCT06810544