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NCT07535437 · ClinicalTrials.gov registry record · Phase 1
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT07535437: Recruiting Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT07535437 is a Phase 1 study that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07535437, a Phase 1 study, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.
Primary Outcome
Three participants will be enrolled at starting dose level and assessed for dose limiting toxicities (DLTs) for 1 full cycle (21 days) in cohort A and 2 full cycles (42 days) for cohort B. Toxicity will be graded according to NCI CTCAE version 5.
Interventions
- DRUG Osimertinib
- DRUG Ivonescimab
- DRUG Dato-DXd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-04-09 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
What NCT07535437 shows while recruiting
NCT07535437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 3 interventions - of which Osimertinib is the first listed.
NCT07535437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07535437 about?
NCT07535437 is a clinical study titled "A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer". The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the D...
What is the current status of trial NCT07535437?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2026-04-09. Estimated completion is 2028-04.
What interventions are being tested in trial NCT07535437?
The interventions under investigation include: Osimertinib (DRUG), Ivonescimab (DRUG), Dato-DXd (DRUG).
Who is sponsoring clinical trial NCT07535437?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07535437's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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