Clinical Trials for Small Cell Lung Cancer

A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer

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.

HealthScout AI summary: Adults with unresectable, advanced, or metastatic NSCLC or SCLC—including both treatment-naïve and previously treated patients—are eligible for this trial evaluating BNT324, a B7-H3-targeted antibody-drug conjugate, in combination with BNT327, a bispecific antibody targeting PD-L1 and VEGF-A. Separate cohorts include NSCLC with and without actionable oncogenic alterations and both first- and later-line treatment settings.

ClinicalTrials.gov ID: NCT06892548

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES

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.

HealthScout AI summary: This trial enrolls patients with advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC to receive PF-08046037, an immune-stimulating antibody-drug conjugate targeting PD-L1 and delivering a TLR7 agonist, either as monotherapy or in combination with sasanlimab (anti-PD-1). Participants must have measurable disease and available tumor tissue, with other eligibility based on prior therapies and comorbidities.

ClinicalTrials.gov ID: NCT06974734

Phase II Study of Diclofenac Salvage in Patients Metastatic Non-Small Cell Lung Cancer With Early Signs of Progression on Single Agent PD(L)-1 Blockade

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Enrolling adults with stage III or IV metastatic non-small cell lung cancer who are experiencing early radiographic progression on at least 12 weeks of single-agent PD-1 or PD-L1 inhibitor immunotherapy, this trial adds diclofenac (a cyclooxygenase-inhibiting NSAID with potential immunomodulatory effects) to ongoing checkpoint inhibitor therapy. Patients must have adequate organ function, ECOG 0-2, and no contraindications to NSAIDs or need for anticoagulation.

ClinicalTrials.gov ID: NCT06731270

A Study of PARG Inhibitor IDE161 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies 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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors (select cohorts: 2L+ cutaneous melanoma, EGFR-mutated or EGFR/ALK/ROS1–negative NSCLC, rare melanomas, other solid tumors; and in combination: 2L+ melanoma and HER2‑negative metastatic breast cancer) receive the HER3-targeting antibody–drug conjugate BNT326 (topoisomerase I payload) as monotherapy or combined with BNT327, a bispecific anti–PD-L1/anti–VEGF-A antibody. Includes a dedicated drug–drug interaction cohort with CYP inhibitors (itraconazole or paroxetine).

ClinicalTrials.gov ID: NCT07070232

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)

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.

HealthScout AI summary: Adults with advanced/metastatic EGFR-mutant NSCLC (ex19del/L858R), ECOG 0–1, after prior EGFR TKI; Part B requires C797X resistance mutation. Single‑agent DZD6008, an oral fourth‑generation, mutant‑selective EGFR TKI with designed activity against C797X (including C797S) and CNS penetration, is given once daily with dose escalation then expansion.

ClinicalTrials.gov ID: NCT06905197

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

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.

HealthScout AI summary: Single-arm study for adults with newly diagnosed advanced/metastatic NSCLC with PD-L1 ≥1% and no prior metastatic systemic therapy, testing intravenous trabedersen (OT-101)—an antisense oligonucleotide targeting TGF-β2 to reduce tumor immune suppression—combined with fixed-dose pembrolizumab. Phase 1 identifies the RP2D of OT-101 (4-days-on/10-days-off IV schedule) with pembrolizumab Q6W, followed by phase 2 assessing efficacy.

ClinicalTrials.gov ID: NCT06579196

MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor

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.

HealthScout AI summary: Adults with relapsed/refractory histiocytic neoplasms (including ECD, LCH, histiocytic sarcoma, Rosai-Dorfman) lacking actionable BRAF/MAP2K alterations or post–BRAF/MEK, plus high‑risk MDS/CMML/MF post‑standard therapy, and multiple relapsed/refractory lymphomas/CLL after ≥2 prior lines, receive oral Q702 (adrixetinib), a TAM kinase (AXL/MERTK) and CSF1R inhibitor given week-on/week-off. The trial assesses safety, RP2D, and preliminary efficacy across disease-specific cohorts.

ClinicalTrials.gov ID: NCT06712810

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or 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.

HealthScout AI summary: Adults with select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Adults with advanced/metastatic NSCLC harboring centrally confirmed NECTIN4 gene amplification (non-squamous and squamous cohorts), previously treated with up to 3 prior lines (including prior platinum/IO or appropriate targeted therapy for actionable drivers), receive zelenectide pevedotin (BT8009) monotherapy. BT8009 is a Nectin-4–targeted Bicycle Toxin Conjugate delivering MMAE; key exclusions include prior MMAE, active/untreated CNS mets, significant ocular disease, and active ILD/pneumonitis.

ClinicalTrials.gov ID: NCT06933329