Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected 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.

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 good performance status and selected locally advanced unresectable or metastatic solid tumors—including certain sarcomas, salivary gland cancer, and triple-negative breast cancer—receive intravenous AVA6000 alone. This investigational prodrug is designed to release doxorubicin when cleaved by fibroblast activation protein (FAP) in tumor-associated stroma.

ClinicalTrials.gov ID: NCT04969835

A Phase 1 Study of SGN-PDL1V in 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.

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 solid tumors and ECOG 0–1 receive PF-08046054, a PD-L1-targeted antibody–drug conjugate that delivers the microtubule inhibitor MMAE, alone or with the PD-1 inhibitor pembrolizumab. Combination cohorts are limited to PD-L1-positive NSCLC or head and neck squamous cell carcinoma.

ClinicalTrials.gov ID: NCT05208762

LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of 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: This trial enrolls adults with previously untreated, stage IV non-squamous or squamous NSCLC without actionable driver mutations, randomizing them to receive pembrolizumab plus platinum-based chemotherapy with or without Tumor Treating Fields (TTFields), a therapy using low-intensity alternating electric fields to disrupt cancer cell mitosis.

ClinicalTrials.gov ID: NCT06216301

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED 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.

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 study enrolls patients with previously treated advanced solid tumors, including primary brain tumors, for PF-07799544, an investigational brain-penetrant MEK inhibitor. Combination cohorts enroll patients with BRAF-altered advanced melanoma or nonmelanoma solid tumors to receive PF-07799544 with PF-07799933, an investigational brain-penetrant BRAF inhibitor; an initial component may use encorafenib instead.

ClinicalTrials.gov ID: NCT05538130

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant 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.

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 locally advanced or metastatic KRAS G12D-mutant solid tumors after progression on or intolerance to standard therapy receive oral zoldonrasib (RMC-9805), an active KRAS G12D inhibitor, alone or with daraxonrasib (RMC-6236), an active pan-RAS inhibitor. Both drugs form cyclophilin A–mediated complexes to disrupt RAS signaling.

ClinicalTrials.gov ID: NCT06040541

A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With ABBV-514 as a Single Agent and in Combination With Budigalimab

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 ECOG 0–1 and refractory advanced solid tumors are eligible for dose escalation; expansion focuses on unresectable or metastatic NSCLC or HNSCC previously treated with platinum chemotherapy and PD-1/PD-L1 blockade, excluding NSCLC with known EGFR mutations or ALK rearrangements. Patients receive intravenous ABBV-514, an investigational anti-CCR8 antibody designed to deplete tumor-infiltrating regulatory T cells, alone or with budigalimab, an investigational anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05005403

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or 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: This trial enrolls adults with advanced or metastatic NSCLC harboring common EGFR mutations (Ex19del or Ex21 L858R), testing subcutaneous amivantamab (a bispecific EGFR/MET antibody) combined with lazertinib as first-line therapy, or with platinum-based chemotherapy as second-line therapy. Patients must have good performance status, measurable disease, and no active ILD.

ClinicalTrials.gov ID: NCT06667076

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic 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.

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, unresectable or metastatic solid tumors, generally after standard therapy, receive DB-1310, a HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, alone or with trastuzumab or osimertinib in selected cohorts. Expansion cohorts include molecularly defined lung, breast, prostate, head and neck, esophageal, and biliary tract cancers; selected osimertinib combination cohorts enroll previously untreated EGFR-mutated NSCLC.

ClinicalTrials.gov ID: NCT05785741

An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation

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 HLA-A*02:01-positive, TP53 R175H-mutant unresectable advanced or metastatic solid tumors who have received at least one approved systemic regimen and have no curative option receive lymphodepleting chemotherapy followed by a single NT-175 infusion and interleukin-2. NT-175 is an autologous T-cell therapy engineered with a T-cell receptor targeting HLA-A*02:01-presented TP53 R175H and edited to reduce TGF-β-mediated suppression.

ClinicalTrials.gov ID: NCT05877599

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV 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: Adults with previously untreated stage IV squamous or nonsquamous NSCLC receive pembrolizumab-based therapy, with chemotherapy according to histology. Investigational combinations add the TIGIT inhibitor vibostolimab, CD27 agonist boserolimab, ILT4 inhibitor MK-4830, or ILT3 inhibitor MK-0482 to pembrolizumab and chemotherapy, or pair pembrolizumab with the B7-H3–directed antibody–drug conjugate ifinatamab deruxtecan or the HER3-directed antibody–drug conjugate HER3-DXd, with or without carboplatin.

ClinicalTrials.gov ID: NCT04165070