Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced 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 or recurrent solid tumors that have progressed after prior treatment and lack suitable standard options receive [225Ac]-FPI-2068, an investigational EGFR/c-MET-targeted alpha-emitting radioimmunotherapy. A nonradioactive FPI-2053 antibody predose is used to optimize biodistribution, with [111In]-FPI-2107 SPECT imaging used to assess uptake and dosimetry.

ClinicalTrials.gov ID: NCT06147037

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant 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: Patients with measurable, unresectable or metastatic KRAS G12D-mutant solid tumors, ECOG 0–1, and at least one prior systemic chemotherapy regimen receive oral debecarasib (LY3962673), a mutant-selective inhibitor of GDP-bound KRAS G12D. Treatment is given alone or with cetuximab or chemotherapy agents.

ClinicalTrials.gov ID: NCT06586515

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion

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 solid tumors harboring HER2 alterations or EGFR exon 20 insertions, after standard options are exhausted or inappropriate, receive oral YH42946, an investigational tyrosine kinase inhibitor targeting HER2 and EGFR signaling. A dose-expansion cohort specifically enrolls patients with HER2 exon 20 insertion–positive NSCLC.

ClinicalTrials.gov ID: NCT06616766

A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, 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: Patients with locally advanced or metastatic solid tumors who have exhausted or are unsuitable for standard treatment receive oral OKN4395, an investigational EP2/EP4/DP1 prostanoid receptor antagonist, alone or with the anti–PD-1 antibody pembrolizumab. Expansion cohorts give OKN4395 alone for selected sarcomas and pancreatic adenocarcinoma, and the combination for NSCLC, microsatellite-stable or MSI-low colorectal cancer, and head and neck squamous cell carcinoma.

ClinicalTrials.gov ID: NCT06789172

A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)

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 previously treated, locally advanced or metastatic NSCLC harboring eligible EGFR or HER2 kinase-domain mutations, measurable extracranial disease, and ECOG performance status 0–1 receive oral BH-30643 twice daily. BH-30643 is a reversible, mutant-selective EGFR/HER2 inhibitor designed to target EGFR exon 20 insertions and resistance mutations, including C797S and T790M, while sparing wild-type EGFR.

ClinicalTrials.gov ID: NCT06706076

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous 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 CLDN1-positive, unresectable or metastatic squamous NSCLC, head and neck, esophageal, or cutaneous carcinoma who are refractory to or intolerant of standard systemic therapy receive intravenous ALE.P02 monotherapy. ALE.P02 is an investigational claudin-1–targeted antibody–drug conjugate that delivers a tubulin-inhibiting payload.

ClinicalTrials.gov ID: NCT06747585

A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in 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 previously treated, measurable, unresectable or metastatic colorectal, non-small-cell lung, or gastric cancer and ECOG performance status 0–1 receive BMS-986490 alone or with bevacizumab. BMS-986490 is a CEACAM5-targeted antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan; bevacizumab targets VEGF.

ClinicalTrials.gov ID: NCT06730750

An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 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 locally advanced or metastatic SMARCA4/BRG1-altered solid tumors and ECOG 0–1 receive oral LY4050784, an investigational selective SMARCA2/BRM ATPase inhibitor designed to exploit SMARCA4-deficient tumors’ dependence on SMARCA2. Expansion cohorts include previously treated NSCLC and non-NSCLC tumors with SMARCA4 loss of function or protein loss.

ClinicalTrials.gov ID: NCT06561685

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab 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 measurable, advanced unresectable or metastatic solid tumors and no suitable curative treatment receive intratumoral or intravenous VET3-TGI, alone or with pembrolizumab. VET3-TGI is an oncolytic vaccinia virus engineered to express CXCR3 and IL-12 and inhibit TGF-β to promote tumor killing and antitumor immunity.

ClinicalTrials.gov ID: NCT06444815

Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)

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 leptomeningeal disease from melanoma (all subtypes, including primary CNS) or non-small cell lung cancer, allowing prior therapies, who receive escalating intrathecal nivolumab (anti-PD-1 immune checkpoint inhibitor) combined with standard intravenous nivolumab. The study tests concurrent intrathecal and intravenous administration to increase CNS drug levels for this population.

ClinicalTrials.gov ID: NCT03025256