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OpenTrials
Completed

NCT Number: NCT01493843

Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica Universitaria Reina Fabiola, Córdoba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)
  • Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Adequate hematologic and end organ function
  • Use of two effective forms of contraception

Exclusion criteria

  • NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma kinase (ALK) gene
  • Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day 1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC
  • Known central nervous system (CNS) disease except for treated brain metastases
  • Type I diabetes
  • Type II diabetes requiring chronic therapy with insulin
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications
  • Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F)

Treatment and study plan

pictilisib

Drug

Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.

Other names: GDC-0941

Placebo

Drug

Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.

Bevacizumab

Drug

Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.

Other names: Avastin

carboplatin

Drug

Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.

paclitaxel

Drug

Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to approximately 2.5 years

  2. PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification

    Time frame: Up to approximately 2.5 years

  3. PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low

    Time frame: Up to approximately 2.5 years

Secondary outcomes

  1. Objective Tumor Response

    Time frame: Up to approximately 2.5 years

  2. Objective Tumor Response in Participants with PIK3CA Amplification

    Time frame: Up to approximately 2.5 years

  3. Objective Tumor Response in Participants with PTEN Loss/low

    Time frame: Up to approximately 2.5 years

  4. Duration of Objective Response (DoR)

    Time frame: Up to approximately 2.5 years

  5. DoR in Participants with PIK3CA Amplification

    Time frame: Up to approximately 2.5 years

  6. DoR in Participants with PTEN Loss/low

    Time frame: Up to approximately 2.5 years

  7. Overall Survival (OS)

    Time frame: Up to approximately 2.5 years

  8. OS in Participants with PIK3CA Amplification

    Time frame: Up to approximately 2.5 years

  9. OS in Participants with PTEN Loss/low

    Time frame: Up to approximately 2.5 years

  10. Percentage of Participants with Adverse Events

    Time frame: Up to approximately 4 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2011
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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