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Completed

NCT Number: NCT02179671

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

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) .

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Key information

Conditions

Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV) 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–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Goodyear, Arizona, United States

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About this study

This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A; tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B; MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled concurrently into multiple cohorts.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of archived tumor tissue sample and mandatory tissue biopsy
  • Patients must have either histologically or cytologically documented NSCLC who present with locally advanced or metastatic stage IIIB-IV disease
  • Life expectancy ≥12 weeks
  • Patients must have measurable disease and at least 1 lesion not previously irradiated
  • World Health Organization (WHO) performance status of 0 or 1

Exclusion criteria

  • Mixed small cell and NSCLC histology
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

Treatment and study plan

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

Primary outcomes

  1. Confirmed Complete Response (CR) Rate

    Time frame: Up to 2 years

    To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    To further assess the efficacy of various sequences. Objective response rate (ORR; per RECIST 1.1 as assessed by the site Investigator) is defined as the number (%) of patients with a confirmed overall response of CR or PR and was based on the evaluable analysis set. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2. Progression-free Survival

    Time frame: Up to 2 years

    Progression-free survival (per RECIST 1.1 as assessed by Investigator) is defined as the date of 1st dose of MEDI4736 until the date of objective disease progression or death. Progression of disease (PD) At least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  3. Duration of Response

    Time frame: Within 12 months

    Duration of response (DoR; per RECIST 1.1 as assessed by the site Investigator) will be defined as the time from the date of 1st documented response (which is subsequently confirmed) until the 1st date of documented progression or death in the absence of disease progression.

  4. Overall Survival

    Time frame: Up to 2 years

    To assess the efficacy of various sequences. In survival follow up at data cut off.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

A Phase IIa, Open-Label, Multi-Center, Multi-Cohort, 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 (Stage IIIB-IV)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2014
Registry last updated
Aug 2, 2019

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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