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 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 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 study enrolls patients with unresectable or metastatic carcinoma, ECOG performance status 0–1, and a lesion available for pretreatment biopsy. Patients receive escalating or expansion doses of BMS-986463, an investigational molecular-glue degrader of the cell-cycle regulator WEE1 kinase.

ClinicalTrials.gov ID: NCT06476808

IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib with Carotuximab in Advanced, EGFR-mutated 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.

No known activity

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

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 stage IV or recurrent/metastatic nonsquamous EGFR-mutated NSCLC are eligible after progression on an EGFR TKI or if EGFR-mutant circulating tumor DNA persists during early first-line osimertinib. All receive osimertinib plus investigational carotuximab, an anti-endoglin (CD105) antibody intended to disrupt angiogenic signaling.

ClinicalTrials.gov ID: NCT05401110

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: Adults with locally advanced or metastatic KRAS G12D-mutated solid tumors, including pancreatic, colorectal, and non-small cell lung cancers, receive the oral KRAS G12D inhibitor INCB161734 alone or with cetuximab, retifanlimab, gemcitabine/nab-paclitaxel, or modified FOLFIRINOX. Prior KRAS G12D inhibitor treatment is excluded.

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: Adults with advanced or metastatic MTAP-loss solid tumors, including NSCLC and recurrent or progressive glioblastoma, whose standard treatment has failed or is unsuitable or unavailable receive oral TNG456 alone or with abemaciclib. TNG456 is an investigational PRMT5 inhibitor designed to preferentially inhibit PRMT5 in MTAP-loss tumors; abemaciclib inhibits CDK4/6.

ClinicalTrials.gov ID: NCT06810544

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS 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: Adults with unresectable or metastatic KRAS-mutant solid tumors who have progressed on, cannot tolerate, or declined appropriate standard therapy receive oral ALTA3263. This investigational KRAS isoform-selective inhibitor is designed to bind mutant KRAS in both active and inactive states, including G12V, G12D, and G12C.

ClinicalTrials.gov ID: NCT06835569

A First-In-Human (FIH) Phase I/II Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations

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: Patients with ECOG performance status 0–1 and relapsed or refractory advanced solid tumors with MET exon 14 alterations, activating MET kinase-domain mutations, or MET amplification are eligible for dose escalation; expansion focuses on unresectable stage IIIB/C or IV NSCLC with MET exon 14 alterations or de novo MET amplification. They receive intravenous VERT-002, an investigational anti-MET antibody designed to promote MET receptor shedding and degradation, reducing MET signaling.

ClinicalTrials.gov ID: NCT06669117

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other 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 or metastatic CDK4-dependent solid tumors, including HR-positive/HER2-negative breast cancer, receive the investigational oral selective CDK4 inhibitor BGB-43395 alone or with fulvestrant or letrozole. Patients with HR-positive breast cancer generally must have received prior endocrine therapy and a CDK4/6 inhibitor where available, although a separate first-line, CDK4/6 inhibitor–naive cohort is included.

ClinicalTrials.gov ID: NCT06120283

A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene

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 KRAS-mutated solid tumors and ECOG 0–1, including PDAC, CRC, and NSCLC, receive oral PF-07934040, an investigational pan-KRAS inhibitor, either alone in later-line cohorts or with standard agents in tumor-specific cohorts. First-line combinations include gemcitabine/nab-paclitaxel for PDAC, FOLFOX/bevacizumab for CRC, and pembrolizumab with or without platinum chemotherapy for NSCLC; later-line CRC may receive PF-07934040 plus cetuximab.

ClinicalTrials.gov ID: NCT06447662