Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-26 @ 11:18 AM
Study NCT ID:
NCT02382406
Status:
TERMINATED
Last Update Posted:
2023-05-23
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC
Sponsor:
Nisha Mohindra, MD
Organization:
Study Overview
Official Title:
A Phase I/II Study of Carboplatin/Nab-Paclitaxel and Pembrolizumab for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was completed. It was fully accrued.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy. All subjects who receive either nab-paclitaxel or pembrolizumab will be evaluable. If 33% of subjects or less have unacceptable toxicity in the first cohort or any subsequent cohort (if necessary), the study will proceed to the Phase II part. If more than 33% have unacceptable toxicity, 12 additional subjects will be enrolled in a second cohort, if necessary. If unacceptable toxicity is seen in more than 33% in Cohort 2, the study will end due to unacceptable toxicity of this drug combination.
The phase II part of the study is a single arm study. All subjects will be treated with carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles.
Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will be obtained in the Phase II part of the study after 4 cycles of study treatment or at the time of progression, whichever comes first.
For subjects without progression of disease after Cycle 4, pembrolizumab will continue every 3 weeks for up to 2 years or until unacceptable toxicity.
The phase II part of the study is a single arm study. All subjects will be treated with carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles.
Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will be obtained in the Phase II part of the study after 4 cycles of study treatment or at the time of progression, whichever comes first.
For subjects without progression of disease after Cycle 4, pembrolizumab will continue every 3 weeks for up to 2 years or until unacceptable toxicity.
Detailed Description:
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
Phase I, Cohort 1 Induction Therapy:
* Carboplatin AUC 6 IV, Day 1
* Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15
* pembrolizumab 2 mg/kg IV, Day 1
* Cycle length: 21 days; number of cycles: 4
Phase I, Cohort 1 Maintenance Therapy:
For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 2\* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 1, Day 1 (C1D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they continue to meet inclusion criteria requirements.
If unacceptable toxicity is seen in Phase I, Cohort 1, 12 additional participants will be enrolled.
Phase I, Cohort 2 Induction Therapy (if necessary):
* Carboplatin AUC 6 IV, Day 1
* Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15
* pembrolizumab 2 mg/kg IV, Day 1 (cycle 2-4 only)
* Cycle length: 21 days; Number of cycles: 4
Phase I, Cohort 2 Maintenance Therapy:
For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 2\* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 2, Day 1 (C2D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they continue to meet inclusion criteria requirements.
Phase II Induction Therapy:
* Carboplatin AUC 6 IV, Day 1
* Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15
* pembrolizumab 200mg IV, Day 1 of each cycle
* Cycle length: 21 days; number of cycles: 4
Phase II Maintenance Therapy:
For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 200 mg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 1, Day 1 (C1D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they meet the requirements.
\*As additional data from ongoing trials becomes available, the dose of pembrolizumab may be adjusted.
INVESTIGATIONAL TREATMENT:
Phase I, Cohort 1 Induction Therapy:
* Carboplatin AUC 6 IV, Day 1
* Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15
* pembrolizumab 2 mg/kg IV, Day 1
* Cycle length: 21 days; number of cycles: 4
Phase I, Cohort 1 Maintenance Therapy:
For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 2\* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 1, Day 1 (C1D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they continue to meet inclusion criteria requirements.
If unacceptable toxicity is seen in Phase I, Cohort 1, 12 additional participants will be enrolled.
Phase I, Cohort 2 Induction Therapy (if necessary):
* Carboplatin AUC 6 IV, Day 1
* Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15
* pembrolizumab 2 mg/kg IV, Day 1 (cycle 2-4 only)
* Cycle length: 21 days; Number of cycles: 4
Phase I, Cohort 2 Maintenance Therapy:
For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 2\* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 2, Day 1 (C2D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they continue to meet inclusion criteria requirements.
Phase II Induction Therapy:
* Carboplatin AUC 6 IV, Day 1
* Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15
* pembrolizumab 200mg IV, Day 1 of each cycle
* Cycle length: 21 days; number of cycles: 4
Phase II Maintenance Therapy:
For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 200 mg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 1, Day 1 (C1D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they meet the requirements.
\*As additional data from ongoing trials becomes available, the dose of pembrolizumab may be adjusted.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: