NCT07465757 Alisertib 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 NCT07465757 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: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07465757 is a hot trial to watch
Small Cell Lung Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07465757 is notable because it evaluates Alisertib in a Phase 2 design sponsored by Puma Biotechnology, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07465757 |
| Official title | A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) (ALISCA-Lung2) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Alisertib |
| Sponsor | Puma Biotechnology, Inc. |
| Geography | Not reported in the indexed record |
| Enrollment | 50 |
| Primary endpoint | Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) |
| Endpoint time frame | From date of first dose through last dose plus 28 days, assessed up to 24 months |
| Primary completion / readout proxy | 2028-03-31 |
Protocol design and endpoint interpretation
The goal of this clinical trial is to determine how well people tolerate treatment with alisertib at different doses when it is used together with paclitaxel to treat people with SCLC. The main question it aims to answer is: * What percentage of side effects, both mild and serious, do participants experience when being treated with alisertib and paclitaxel based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0)? The study will consist of different groups, called cohorts, in which alisertib will be studied at increasing doses. Participants in the first group, Cohort 1, will take 30 mg of alisertib by mouth 2 times a day. The dose will increase by 10 mg 2 times a day for each new cohort of participants joining the study. Side effects will be checked during the study, and the decision to increase the dose of alisertib will be based on the specific side effects experienced during t
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment. Planned enrollment of 50 participants across Not reported in the indexed record 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.
- Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) (From date of first dose through last dose plus 28 days, assessed up to 24 months) — Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after the last dose.
Readout outlook and evidence gap
The current protocol points to 2028-03-31 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: Alisertib is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Puma Biotechnology, Inc. is resolved to a normalized organization record in LOS ANGELES 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
NCT07465757 provides a focused lens on Small Cell Lung Cancer development. Its value will be determined by whether Alisertib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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