Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, 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: Enrolls adults with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors (including CRPC, NSCLC/SCLC, CRC, HNSCC, ovarian/cervical/endometrial cancers, TNBC, and esophageal SCC) who have progressed after their most recent therapy and have no suitable standard option, with ECOG 0–2 and adequate organ function (measurable disease required except in CRPC; prior Lu-177–PSMA excluded for CRPC). Patients receive 177Lu-BetaBart, a lutetium-177–labeled anti–B7-H3 (CD276) monoclonal antibody delivering beta-particle radiation as systemic radioimmunotherapy in a dose-escalation/expansion design.

ClinicalTrials.gov ID: NCT07189871

A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients 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 metastatic/advanced NSCLC, gastroesophageal, colorectal, hepatocellular, pancreatic, or head and neck squamous cell carcinoma that has progressed on or is intolerant to standard systemic therapy (ECOG 0–2; measurable disease) receive DM005 (YH013) monotherapy IV Q3W. DM005 is a first-in-human bispecific antibody–drug conjugate targeting EGFR and c-MET, intended to preferentially bind EGFR/MET co-expressing tumors to enhance internalization and cytotoxic payload delivery, with dose escalation/expansion to define safety/MTD and assess preliminary activity.

ClinicalTrials.gov ID: NCT06515990

A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With Active EGFR Mutation Locally Advanced or Metastatic NSCLC

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.

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 involves adults with unresectable locally advanced or metastatic NSCLC harboring active EGFR mutations, including C797S, who have progressed on osimertinib or another third-generation EGFR-TKI, receiving the investigational fourth-generation EGFR tyrosine kinase inhibitor H002 to assess its safety and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT05519293

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

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.

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: The trial investigates the use of AG01, an anti-progranulin/GP88 monoclonal antibody, in patients with relapsed or refractory advanced solid tumors, including triple negative breast cancer, hormone-resistant breast cancer, non-small cell lung cancer, and mesothelioma, who have no remaining effective treatment options. AG01 is administered biweekly to evaluate its safety, tolerability, and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT05627960

An Open-Label, Phase 1/2 Study to Evaluate Safety, Efficacy, and Pharmacokinetics of EU101, an Agonistic Anti-CD137 (4-1BB) Monoclonal Antibody in Patients 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.

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 is focused on patients with metastatic or locally advanced solid tumors, specifically colorectal cancer and non-small cell lung cancer, investigating the safety and efficacy of EU101, an agonistic monoclonal antibody targeting the 4-1BB receptor to enhance immune response.

ClinicalTrials.gov ID: NCT04903873

First in Human Phase 1 Study of AOH1996 in Patients With Refractory 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.

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 involves adult patients with refractory solid tumors unresponsive or declining standard treatments, evaluating the PCNA inhibitor AOH1996, which targets a cancer-specific variant to impair DNA replication and repair, dosed orally twice daily in a 28-day cycle.

ClinicalTrials.gov ID: NCT05227326

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

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.

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 involves adult patients with advanced or metastatic solid tumors such as melanoma and non-small cell lung cancer who have relapsed after standard treatments, testing the investigational agent ST-067 alone or with pembrolizumab and obinutuzumab to enhance immune response against tumor cells.

ClinicalTrials.gov ID: NCT04787042

Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

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.

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 with advanced solid tumors harboring RET gene abnormalities, including both NSCLC and other solid tumors, regardless of prior RET inhibitor exposure. Patients receive TAS0953/HM06 (vepafestinib), an oral selective RET tyrosine kinase inhibitor active against resistance mutations and designed for enhanced CNS penetration.

ClinicalTrials.gov ID: NCT04683250

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.

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 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

Phase 1/2 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant 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.

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: Eligible patients are adults with advanced NSCLC, head and neck squamous cell carcinoma, cervical cancer, or uterine carcinoma, whose tumors express the NEO-201 antigen and who have progressed after standard therapies. Treatment consists of NEO-201 (a monoclonal antibody targeting tumor-associated O-glycans and CEACAM5/1 pathway) in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT03476681