NCT02179671

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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

July 25, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

June 30, 2014

Results QC Date

June 1, 2017

Last Update Submit

August 1, 2019

Conditions

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

Keywords

Lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

  • Confirmed Complete Response (CR) Rate

    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.

    Up to 2 years

Secondary Outcomes (4)

  • Objective Response Rate (ORR)

    Up to 2 years

  • Progression-free Survival

    Up to 2 years

  • Duration of Response

    Within 12 months

  • Overall Survival

    Up to 2 years

Study Arms (4)

Gefitinib with a Seq. Switch to a MEDI4736

EXPERIMENTAL

Gefitinib once daily followed by MEDI4736

Drug: Gefitinib

AZD9291 with a Seq. Switch to a MEDI4736

EXPERIMENTAL

AZD9291 once daily followed by MEDI4736

Drug: AZD9291

Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736

EXPERIMENTAL

Selumetinib twice daily + docetaxel, followed by MEDI4736

Drug: Selumetinib+Docetaxel

Tremelimumab with a Seq. Switch to a MEDI4736

EXPERIMENTAL

Tremelimumab every 4 weeks followed by MEDI4736

Drug: Tremelimumab

Interventions

GefitinibDRUG

Gefitinib once daily followed by MEDI4736

Gefitinib with a Seq. Switch to a MEDI4736
AZD9291DRUG

AZD9291 once daily followed by MEDI4736

AZD9291 with a Seq. Switch to a MEDI4736
Selumetinib+DocetaxelDRUG

Selumetinib twice daily + docetaxel, followed by MEDI4736

Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736
TremelimumabDRUG

Tremelimumab every 4 weeks followed by MEDI4736

Tremelimumab with a Seq. Switch to a MEDI4736

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Goodyear, Arizona, 85338, United States

Location

Research Site

Washington D.C., District of Columbia, 20007, United States

Location

Research Site

Augusta, Georgia, 30912, United States

Location

Research Site

Marietta, Georgia, 30060, United States

Location

Research Site

Ashland, Kentucky, 41101, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

Mineola, New York, 11501, United States

Location

Research Site

Huntersville, North Carolina, 28078, United States

Location

Research Site

Spokane, Washington, 99208-1129, United States

Location

Research Site

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Gefitinibosimertinibtremelimumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Phillip Dennis
Organization
AstraZeneca
Phillip.Dennis@astrazeneca.com
1 + 301-398-5549

Study Officials

  • Samir N. Khleif, MD

    International Coordinating Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

July 25, 2014

Primary Completion

June 11, 2016

Study Completion

June 11, 2016

Last Updated

August 2, 2019

Results First Posted

August 2, 2019

Record last verified: 2019-08

Locations

US(10)