Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1, First-in-Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2

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.

HealthScout AI summary: Adults with advanced or recurrent HER2-expressing solid tumors (IHC 3+ or 2+/ISH+) who have exhausted standard therapy options are eligible to receive XMT-2056, a novel HER2-targeted antibody-drug conjugate with a STING agonist payload designed to activate tumor and immune cell STING pathways and induce ADCC.

ClinicalTrials.gov ID: NCT05514717

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.

HealthScout 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.

HealthScout 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

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

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.

HealthScout AI summary: Adults with locally advanced or metastatic solid tumors harboring oncogene amplifications who have progressed on or are ineligible for standard therapies may receive oral BBI-355, a selective CHK1 inhibitor, either as monotherapy or combined with erlotinib (EGFR inhibitor) or futibatinib (FGFR inhibitor) in cohorts defined by specific gene amplifications. Key exclusions include certain oncogenic mutations, prior targeted therapies, CNS involvement, and serious comorbidities.

ClinicalTrials.gov ID: NCT05827614

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.

HealthScout 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

An Open-label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer

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.

HealthScout AI summary: Enrolling adults with advanced NSCLC who have progressed after platinum-based chemotherapy and PD-(L)1 therapy, this study investigates the novel NFE2L2/KEAP1/CUL3 inhibitor MGY825 as monotherapy, with cohorts both requiring and not requiring these mutations. Patients must have at least one measurable lesion and be willing to undergo multiple biopsies.

ClinicalTrials.gov ID: NCT05275868

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.

HealthScout 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.

HealthScout 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 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients with Advanced Solid Tumors or Lymphomas

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors or designated lymphomas (with confirmed CD161 expression) who have failed or are intolerant to standard therapies, to receive the investigational anti-CD161 monoclonal antibody IMT-009 (which blocks an inhibitory NK/T cell pathway) as monotherapy or in combination with fruquintinib.

ClinicalTrials.gov ID: NCT05565417

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.

HealthScout 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