Clinical trial · Interventional
Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer
A Two-Part, Phase 1b/2, Multicenter, Open-Label, Dose Escalation and Double-Blind, Randomized, Placebo-Controlled, Dose Expansion Study of the Safety, Efficacy and Pharmacokinetics of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Subjects With Locally Advanced and Metastatic Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Navtemadlin | Drug | Navtemadlin | ALIAS |
| Navtemadlin Placebo | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Navtemadlin in combination with pembrolizumab
- description
- Navtemadlin will be administered orally, once daily (QD), on days 1-7 in a 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of a 21-day cycle.
- interventionNames
- Drug: Navtemadlin
- Drug: Pembrolizumab
- type
- PLACEBO_COMPARATOR
- label
- Navtemadlin placebo in combination with pembrolizumab
- description
- Navtemadlin placebo will be administered orally, once daily (QD), on days 1-7 in a 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of a 21-day cycle.
- interventionNames
- Drug: Navtemadlin Placebo
- Drug: Pembrolizumab
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0-1 * Histologically or cytologically confirmed diagnosis of NSCLC documented as TP53WT * Locally advanced or metastatic disease; must have completed up to 4 cycles of platinum-based chemo plus CPI and achieved a CR or PR per RECIST V1.1 * Adequate hematologic, hepatic and renal function (within 14 days) Exclusion Criteria: * Symptomatic or uncontrolled central nervous system (CNS) metastases * Prior treatment with a MDM2 inhibitor * Grade 2 or higher QTc prolongation (\>480 msec per NCI-CTCAE criteria version 5.0) * History of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks * History of major organ transplant * Active pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis * Prior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 days * Medical condition, serious intercurrent illness, psychiatric condition or other circumstance that, in the Investigator's judgment could jeopardize the subject's safety, or that could interfere with study objectives
References
Publications (0)
Data not yet available