NCT07551635 Camibirstat Extensive stage Small Cell Lung Cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07551635 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07551635 is a hot trial to watch

Extensive stage Small Cell Lung Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07551635 is notable because it evaluates Camibirstat in a Phase 2 design sponsored by Dana-Farber Cancer Institute, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This is a single-arm, phase II clinical trial evaluating the efficacy and safety of FHD-286, a SMARCA4/2 inhibitor, in participants with POU2F3-expressing small cell lung cancer who have received at least one prior line of platinum-based therapy. All participants will receive FHD-286 orally once daily in 21-day cycles. The primary objective is to assess the objective response rate of FHD-286 in this population. The names of the study drug involved in this study is: • FHD-286 (a small-molecule SMARCA4/2 ATPase (BRG1 and BRM) inhibitor targeting the SWI/SNF chromatin remodeling complex (also known as the BAF complex)

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Objective Response Rate (ORR) (Observed on treatment; Time frame is variable by patient as duration of treatment is event-driven per protocol section 5.5. Disease assessed on treatment every 2 cycles (cycle duration=21 days). Response follow-up expected up to 12 months.) — ORR is the percentage of participants achieving complete or partial response on treatment based on RECIST v1.1 criteria (Eisenhauer et al Eur J Ca 45:228-247, 2009).

Readout outlook and evidence gap

The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Camibirstat is indexed as Small molecule drug, with target SMARCA2 x SMARCA4, mechanism SMARCA2 inhibitors, SMARCA4 inhibitors, and global highest development status Phase 2.

Company & Deal Intelligence MCP profile: Dana-Farber Cancer Institute, Inc. is resolved to a normalized organization record in SUFFOLK COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07551635 provides a focused lens on Extensive stage Small Cell Lung Cancer development. Its value will be determined by whether Camibirstat can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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