Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Conditions

• Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Gefitinib — DRUG
  Gefitinib once daily followed by MEDI4736
• AZD9291 — DRUG
  AZD9291 once daily followed by MEDI4736
• Selumetinib+Docetaxel — DRUG
  Selumetinib twice daily + docetaxel, followed by MEDI4736
• Tremelimumab — DRUG
  Tremelimumab every 4 weeks followed by MEDI4736

Study Details

Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .

Key Dates

Start date

Jul 25, 2014

Status verified

Aug 2019

Primary completion

Jun 11, 2016

Completion

Jun 11, 2016

Study Design

Enrollment

32 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Gefitinib with a Seq. Switch to a MEDI4736
  Gefitinib once daily followed by MEDI4736
• Experimental: AZD9291 with a Seq. Switch to a MEDI4736
  AZD9291 once daily followed by MEDI4736
• Experimental: Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736
  Selumetinib twice daily + docetaxel, followed by MEDI4736
• Experimental: Tremelimumab with a Seq. Switch to a MEDI4736
  Tremelimumab every 4 weeks followed by MEDI4736

Primary Outcome Measure

Confirmed Complete Response (CR) Rate [ Time Frame: Up to 2 years ]

Locations (10)

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