Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
CompletedPhase 3Results postedLast updated 26 February 2021
What this trial tests
Phase 3 trial testing Paclitaxel in Non-squamous Non-small Cell Lung Cancer in 595 participants. Completed in 21 February 2020.
18 and older, any sex, with Non-squamous Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS) in the Lung Subtype Panel Positive SubgroupPrimary· From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Group
Value
95% CI
Investigator's Choice Chemotherapy
9.2
5.1 – 11.7
Veliparib + Carboplatin + Paclitaxel
11.2
7.5 – 15.8
Progression Free Survival (PFS) in the Lung Subtype Panel Positive SubgroupSecondary· From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methodolo
Group
Value
95% CI
Investigator's Choice Chemotherapy
5.2
2.8 – 6.2
Veliparib + Carboplatin + Paclitaxel
6.3
3.5 – 7.4
Objective Response Rate (ORR) in the Lung Subtype Panel Positive SubgroupSecondary· Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.
Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions,
Group
Value
95% CI
Investigator's Choice Chemotherapy
30.0
16.6 – 46.5
Veliparib + Carboplatin + Paclitaxel
22.5
10.8 – 38.5
Overall Survival in All ParticipantsSecondary· From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Group
Value
95% CI
Investigator's Choice Chemotherapy
12.1
10.0 – 13.7
Veliparib + Carboplatin + Paclitaxel
12.1
10.4 – 14.9
Progression Free Survival (PFS) in All ParticipantsSecondary· From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of d
Group
Value
95% CI
Investigator's Choice Chemotherapy
6.7
5.6 – 7.2
Veliparib + Carboplatin + Paclitaxel
5.9
5.0 – 6.5
Objective Response Rate (ORR) in All ParticipantsSecondary· Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.
Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters,
Group
Value
95% CI
Investigator's Choice Chemotherapy
29.0
23.9 – 34.5
Veliparib + Carboplatin + Paclitaxel
26.2
21.3 – 31.6
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Investigator's Choice Chemotherapy
Serious: 98/288 (34%)
Deaths: 255/297
Veliparib + Carboplatin + Paclitaxel
Serious: 121/293 (41%)
Deaths: 250/298
Serious adverse events (151 terms)
Reaction
System
Investigator's Choice Chem…
Veliparib + Carboplatin + …
PNEUMONIA
Infections and infestations
—
—
ANAEMIA
Blood and lymphatic system disorders
—
—
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
—
—
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
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—
PERICARDIAL EFFUSION
Cardiac disorders
—
—
NEUTROPENIA
Blood and lymphatic system disorders
—
—
THROMBOCYTOPENIA
Blood and lymphatic system disorders
—
—
VOMITING
Gastrointestinal disorders
—
—
DEHYDRATION
Metabolism and nutrition disorders
—
—
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
—
—
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
—
—
ATRIAL FIBRILLATION
Cardiac disorders
—
—
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
—
—
SEPSIS
Infections and infestations
—
—
METASTASES TO CENTRAL NERVOUS SYSTEM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 26 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02264990.