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NCT05705466 | Withdrawn | Non Small Cell Lung Cancer


Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer
Sponsor:

Kartos Therapeutics, Inc.

Brief Summary:

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.

Condition or disease

Non Small Cell Lung Cancer

Intervention/treatment

Navtemadlin

Navtemadlin Placebo

Pembrolizumab

Phase

Phase 1

Phase 2

Detailed Description:

This is a 2 part, phase 1b/2, maintenance study for patients who have achieved a partial response (PR) or complete response (CR) after completion of up to 4 cycles of a combination platinum-based chemotherapy plus CPI regimen. Phase 1b is a 3+3 dose escalation design that will be used to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of navtemadlin in combination with pembrolizumab. A Safety Review Committee (SRC) will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses. Phase 2 will evaluate the efficacy and safety of the RP2D of navtemadlin plus pembrolizumab compared to navtemadlin placebo plus pembrolizumab. Each Arm will have approximately 40 subjects enrolled for a total of approximately 80 subjects. Eligible subjects will be randomized 1:1. This part of the study has a randomized, controlled, double-blind design. A stratified, permuted-block randomization scheme will be used for treatment allocation.

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking: Quadruple
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2027
Arm Intervention/treatment

Experimental: Navtemadlin in combination with pembrolizumab

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.

Drug: Navtemadlin

Drug: Pembrolizumab

Placebo Comparator: Navtemadlin placebo in combination with pembrolizumab

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.

Drug: Navtemadlin Placebo

Drug: Pembrolizumab

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

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Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

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