Clinical trial 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
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
Keywords: Lung cancer; NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2014-07-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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) .

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirmed Complete Response (CR) Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Progression-free Survival
timeFrame: Up to 2 years
measure: Duration of Response
timeFrame: Within 12 months
measure: Overall Survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Research Site
state: Arizona
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Ashland
country: United States
facility: Research Site
state: Kentucky
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Mineola
country: United States
facility: Research Site
state: New York
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: International Coordinating Investigator
name: Samir N. Khleif, MD
role: PRINCIPAL_INVESTIGATOR
References: