Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated 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: Eligible patients are adults with advanced or metastatic solid tumors harboring STK11 mutations, including NSCLC, who will receive the investigational oral CoREST inhibitor TNG260 (which targets epigenetic modulation) in combination with pembrolizumab. The trial excludes those with uncontrolled comorbidities, untreated CNS metastases, or other concurrent malignancies.

ClinicalTrials.gov ID: NCT05887492

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced 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.

TrialFetch AI summary: Eligible patients are adults with advanced, refractory solid tumors (including soft-tissue sarcoma, triple-negative breast cancer, NSCLC, cervical cancer, ovarian cancer, or KRAS-mutant pancreatic ductal adenocarcinoma), who have not previously received anthracyclines. The trial investigates Spedox-6, a novel human serum albumin-encapsulated doxorubicin formulation designed to enhance tumor delivery and reduce cardiotoxicity, given IV every 21 days at escalating doses (with filgrastim support at higher doses).

ClinicalTrials.gov ID: NCT07064018

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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 solid tumors—including HNSCC, NSCLC, GI, GU, gynecologic, sarcoma, neuroendocrine, and NUT carcinoma—who have measurable disease and good performance status, to evaluate the intravenous BRD4 degrader MT-4561 administered weekly. MT-4561 is a novel agent targeting BRD4 for ubiquitin-mediated degradation and is being assessed primarily for safety and initial efficacy in this biomarker-unselected population.

ClinicalTrials.gov ID: NCT06943521

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing 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: This trial enrolls adults with advanced, relapsed or refractory HER3-expressing solid tumors (including cutaneous melanoma, EGFR-mutant NSCLC, and HR+/HER2- breast cancer) who have progressed following or are ineligible for standard therapies. Patients receive intravenous ENV-501, a HER3-targeting antibody-drug conjugate designed to deliver a cytotoxic payload selectively to HER3-expressing tumor cells.

ClinicalTrials.gov ID: NCT06956690

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

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: Enrolling adults with locally advanced or metastatic epithelial cancers (including multiple breast cancer subtypes, NSCLC, cervical, prostate, pancreatic, head and neck, endometrial, ovarian, gastric/GEJ, or urothelial carcinomas) who have progressed after ≥2 prior therapies and lack standard options, this study delivers IV DR-0202, a bispecific antibody targeting CLEC7A on myeloid cells and a tumor-associated antigen, aiming to activate myeloid-driven phagocytosis and antitumor immunity.

ClinicalTrials.gov ID: NCT06999187

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally 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: This trial is enrolling adults with previously treated, locally advanced or metastatic solid tumors (including urothelial carcinoma and other Nectin-4–positive types) who have measurable disease and good performance status. Patients receive [225Ac]Ac-AKY-1189, an investigational Nectin-4–targeting radiopharmaceutical that delivers actinium-225 directly to tumor cells, in up to six cycles following Nectin-4 PET imaging confirmation.

ClinicalTrials.gov ID: NCT07020117

A Phase 1, Open-label Study of Oral BDTX-4933 in Patients With KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

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—such as NSCLC (KRAS non-G12C), melanoma (BRAF/NRAS), histiocytic neoplasms, thyroid carcinoma, colorectal carcinoma (BRAF Class II/III), or other BRAF-mutant tumors—who have exhausted standard therapies, to receive oral BDTX-4933, a brain-penetrant RAF/RAS clamp inhibitor targeting a range of RAS/MAPK pathway mutations. The study includes dose escalation and expansion phases to assess safety and preliminary efficacy.

ClinicalTrials.gov ID: NCT05786924

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic hepatocellular carcinoma or squamous-cell non-small cell lung cancer who have progressed after at least one prior systemic therapy (including immune checkpoint inhibitors and platinum-based chemotherapy for NSCLC), and randomizes patients to receive intravenous ABBV-324 (investigational agent with undisclosed mechanism) or lenvatinib. Both dose escalation and optimization phases are included, with ABBV-324 given as monotherapy.

ClinicalTrials.gov ID: NCT06858813

An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.

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/metastatic KRAS‑mutant solid tumors (e.g., PDAC, CRC, NSCLC, platinum‑resistant serous ovarian, cholangiocarcinoma, urothelial) after at least one prior therapy, ECOG 0–1, receive WEF‑001 monotherapy. WEF‑001 is a first‑in‑class macropinocytosis‑exploiting conjugate designed to selectively deliver a cytotoxic payload to KRAS‑mutant tumors; dose‑finding followed by expansion cohorts.

ClinicalTrials.gov ID: NCT07148128

A Phase 1 Study of ASP5834 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS Mutations or KRAS 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.

TrialFetch AI summary: Adults with unresectable/metastatic solid tumors harboring KRAS G12V/D/C/R/A or G13D mutations or KRAS amplification (ECOG 0–1, measurable disease) receive IV ASP5834, a first‑in‑human pan‑KRAS targeted protein degrader designed to eliminate multiple KRAS variants; dose-expansion includes PDAC, NSCLC, and other non-CRC tumors. Separate colorectal cancer cohorts test ASP5834 combined with panitumumab in KRAS‑mutant mCRC after standard therapies.

ClinicalTrials.gov ID: NCT07094204