Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Nivolumab

Veliparib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Poly(ADP-ribose) Polymerase Inhibitors

Folinic Acid

Folate

Vitamin B9

Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

intravenous; administered on Day 1 via infusion in a 21-day cycle

pemetrexed

nivolumab

paclitaxel

oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle

veliparib

carboplatin

AbbVie Inc.

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion).

A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.

Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 Dose-Escalation and Phase 2 Randomized, Open-Label Study of Nivolumab and Veliparib in Combination With Platinum Doublet Chemotherapy in Subjects With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.

OS is defined as the number of days from the date of randomization to the date of death. For subjects who did not die, their data will be censored at the date of last study visit or the last known date to be alive, whichever is later.

DOR is defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death due to disease progression.

ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).

AbbVie

Pembrolizumab

Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days

Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only)

Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days

Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone

500 mg/m2 day 1 of 21 day cycle (for non-squamous only)

Pemetrexed (Chemotherapy)

100 mg/m2 days 1,8 of 21 day cycle x 4 cycles

Nab-paclitaxel (Chemotherapy)

Megan Baumgart

The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.

Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

A Pilot Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

Determine the rate of treatment-limiting toxicities in patients with advanced non-small cell lung cancer with ECOG PS 2 who are treated with pembrolizumab and single-agent chemotherapy

Determine the proportion of patients who achieve a complete or partial response as their best overall response based on RECIST v1.1 criteria will be evaluated. Patients with nonevaluable or unknown response status will be considered nonresponders.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT02944396	Non-Small Cell ...	pemetrexed nivolumab paclitaxel veliparib carboplatin	18 Years -	AbbVie
Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2	NCT04297605	Non-small Cell ...	Pembrolizumab Pemetrexed (Che... Nab-paclitaxel ...	18 Years -	University of Rochester

Spots Global Cancer Trial Database for eastern cooperative oncology group (ecog)