Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Conditions

• Recurrent Squamous Cell Lung Carcinoma
• Stage IV Squamous Cell Lung Carcinoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Docetaxel — DRUG
  Given IV
• Durvalumab — BIOLOGICAL
  Given IV
• Erlotinib Hydrochloride — DRUG
  Given PO
• FGFR Inhibitor AZD4547 — DRUG
  Given PO
• Ipilimumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Nivolumab — BIOLOGICAL
  Given IV
• Palbociclib — DRUG
  Given PO
• Pharmacological Study — OTHER
  Correlative studies
• Rilotumumab — BIOLOGICAL
  Given IV
• Talazoparib — DRUG
  Given PO
• Taselisib — DRUG
  Given PO
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Key Dates

Start date

Jul 8, 2014

Status verified

May 2023

Primary completion

Apr 1, 2022

Completion

Apr 15, 2022

Study Design

Enrollment

1,864 participants (actual)

Arms

• Arm: S1400A Arm I (MEDI4736) (CLOSED TO ACCRUAL 12/2015)
  Patients with tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm I receive anti-B7H1 monoclonal antibody MEDI4736 IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
• Arm: S1400A Arm II (CLOSED TO ACCRUAL 4/2015)
  Patients with tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)
• Arm: S1400A Arm III (MEDI4736)
  For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12- month periods will be allowed. Patients registered to Arm III receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
• Arm: S1400B Arm I (taselisib) (CLOSED TO ACCRUAL 12/12/2016)
  Patients with tumors positive for PI3KCA randomized to Arm I receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400B Arm II (CLOSED TO ACCRUAL 12/18/2015)
  Patients with tumors positive for PI3KCA randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)
• Arm: S1400B Arm III (taselisib) (CLOSED TO ACCRUAL 12/12/2016)
  Re-Registration Treatment with GDC-0032 (Taselisib). Upon progression patients in Arm 2 may be eligible for Re-Registration to receive GDC-0032. Patients will receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400C Arm I (palbociclib)
  Patients with tumors positive for CDK4/6, CCND1, CCND2, and CCND3 randomized to Arm I receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400C Arm II (CLOSED TO ACCRUAL 12/18/2015)
  Patients with tumors positive for CDK4, CCND1, CCND2, and CCND3 randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)
• Arm: S1400C Arm III (palbociclib)
  Re-Registration Treatment with palbociclib. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive palbociclib. Patients will receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400D Arm I (AZD4547) (CLOSED TO ACCRUAL 04/12/2017)
  Patients with tumors positive for FGFR1, FGFR2, and FGFR3 randomized to Arm I receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400D Arm II (CLOSED TO ACCRUAL 10/31/2016)
  Patients with tumors positive for FGFR1, FGFR2, and FGFR3 randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)
• Arm: S1400D Arm III (AZD4547) (CLOSED TO ACCRUAL 10/31/2016)
  Re-Registration Treatment with AZD4547. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive AZD4547. Patients will receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400E Arm I (CLOSED TO ACCRUAL 11/2014)
  Patients with tumors positive for HGF/c-MET randomized to Arm I receive rilotumumab IV on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (permanently closed to accrual on 11/25/14)
• Arm: S1400E Arm II (CLOSED TO ACCRUAL 11/2014)
  Patients with tumors positive for HGF/c-MET randomized to Arm II receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (permanently closed to accrual on 11/25/14)
• Arm: S1400F (durvalumab, tremelimumab)
  Patients with disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment receive durvalumab (IV over 60 minutes) and tremelimumab (IV over 60 minutes) on day 1 for courses 1-4 and durvalumab IV alone on day 1 of course 5 and subsequent courses until disease progression or unacceptable toxicity. Courses repeat every 28 days.
• Arm: S1400G (talazoparib)
  Patients with tumors positive for homologous recombination repair deficiency receive talazoparib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400I Arm I (nivolumab, ipilimumab)
  Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study randomized to Arm I receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third cycle. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
• Arm: S1400I Arm II (nivolumab)
  Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study randomized to Arm II receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Screen Success Rate [ Time Frame: From date of registration to pre-screening or screening component until sub-study registration or death, a median of 3.5 months (IQR 2.0-6.0) in the pre-screened group and 0.9 months (IQR 0.7-1.1) in the screened at progression group. ]

Locations (998)

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