Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

NCT ID: NCT03334617

Last Updated: 2025-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2026-09-11

Brief Summary

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This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

Detailed Description

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This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic non-small cell lung cancer (NSCLC) who have progressed on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study is modular in design, consisting of a number of treatment cohorts, allowing evaluation of the efficacy, safety, and tolerability of multiple treatment arms. There is currently no established therapy for participants who have received immune checkpoint inhibitors and platinum-doublet therapies, and novel treatments are urgently needed.

This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

Within each module, there will be treatment cohorts.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Module 1 Cohort A.1.HRR: Durvalumab 1500 mg + Olaparib 300 mg

Participants with detectable aberrations, mutation detected in a homologous recombination repair gene (HRRm) will receive IV infusion of durvalumab 1500 mg every 4 weeks (Q4W) in combination with oral olaparib 300 mg (2 × 150 mg) tablets twice a day (BD) until disease progression is confirmed.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Olaparib

Intervention Type DRUG

Participants will receive oral tablets of olaparib as stated in arm description.

Module 1 Cohort A.1.LKB: Durvalumab 1500 mg + Olaparib 300 mg

Participants with detectable aberrations in liver kinase B1 (LKB1) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Olaparib

Intervention Type DRUG

Participants will receive oral tablets of olaparib as stated in arm description.

Module 1 Cohort B.1.PRI: Durvalumab 1500 mg + Olaparib 300 mg

Participants who had anti-programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (primary resistance; PRI) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Olaparib

Intervention Type DRUG

Participants will receive oral tablets of olaparib as stated in arm description.

Module 1 Cohort B.1.ACQ: Durvalumab 1500 mg + Olaparib 300 mg

Participants who had progressive disease \> 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (acquired resistance; ACQ) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral olaparib 300 mg (2 × 150 mg) tablets BD until disease progression is confirmed.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Olaparib

Intervention Type DRUG

Participants will receive oral tablets of olaparib as stated in arm description.

Module 2 Cohort B.2.PRI: Durvalumab 1500 mg + Danvatirsen 200 mg

Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants will receive AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Danvatirsen

Intervention Type DRUG

Participants will receive IV infusion of danvatirsen as stated in arm description.

Module 2 Cohort B.2.ACQ: Durvalumab 1500 mg + Danvatirsen 200 mg

Participants who had progressive disease \> 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of AZD9150 (danvatirsen) 200 mg as loading dose on Days 1, 3, 5 of Cycle 0 (7-day-lead-in period). Thereafter, participants will receive AZD9150 200 mg every week (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Danvatirsen

Intervention Type DRUG

Participants will receive IV infusion of danvatirsen as stated in arm description.

Module 3 Cohort A.3.ATM: Durvalumab 1500 mg + AZD6738 240 mg

Participants who are ataxia telangiectasia mutated (ATM)-deficiecy will receive oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD in each cycle between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 3 Cohort B.3.PRI: Durvalumab 1500 mg + AZD6738 240 mg

Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 3 Cohort B.3.ACQ: Durvalumab 1500 mg + AZD6738 240 mg

Participants who had progressive disease \> 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive oral AZD6738 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral AZD6738 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 4 Cohort A.4.RIC: Durvalumab 1500 mg + Vistusertib 125 mg

Participants with detectable genetic amplifications in rapamycin-insensitive companion of mechanistic target of rapamycin complex-2 (RICTOR) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral vistusertib 125 mg tablets BD on an intermittent dosing schedule of 2 days on, 5 days off, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Vistusertib

Intervention Type DRUG

Participants will receive oral tablets of vistusertib as stated in arm description.

Module 5 Cohort A.5.73H: Durvalumab 1500 mg + Oleclumab 3000 mg

Participants with high expression of cluster of differentiation 73 (CD73) will receive IV infusion of oleclumab 3000 mg every 2 weeks (Q2W) for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Oleclumab

Intervention Type DRUG

Participants will receive IV infusion of oleclumab as stated in arm description.

Module 5 Cohort B.5.PRI: Durvalumab 1500 mg + Oleclumab 3000 mg

Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Oleclumab

Intervention Type DRUG

Participants will receive IV infusion of oleclumab as stated in arm description.

Module 5 Cohort B.5.ACQ: Durvalumab 1500 mg + Oleclumab 3000 mg

Participants who had progressive disease \> 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of oleclumab 3000 mg Q2W for 2 cycles and then Q4W thereafter in combination with IV infusion of durvalumab 1500 mg Q4W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Oleclumab

Intervention Type DRUG

Participants will receive IV infusion of oleclumab as stated in arm description.

Module 6 Cohort A.6.HER2e: Durvalumab 1120 mg + Trastuzumab deruxtecan 5.4mg/kg

Participants whose tumours express human epidermal growth factor receptor 2 (HER2) mutations will receive IV infusion of trastuzumab deruxtecan (T-DXd) 5.4 mg/kg every 3 weeks (Q3W) in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Trastuzumab deruxtecan

Intervention Type DRUG

Participants will receive IV infusion of trastuzumab deruxtecan as stated in arm description.

Module 6 Cohort A.6.HER2m: Durvalumab 1120 mg + Trastuzumab deruxtecan 5.4mg/kg

Participants whose tumours harbour selected HER2 mutations will receive IV infusion of T-DXd 5.4 mg/kg Q3W in combination with IV infusion of durvalumab 1120 mg Q3W, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Trastuzumab deruxtecan

Intervention Type DRUG

Participants will receive IV infusion of trastuzumab deruxtecan as stated in arm description.

Module 7 Cohort B.7.ACQ: Durvalumab 1500 mg + Cediranib 20 mg

Participants who had progressive disease \> 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral cediranib (AZD2171) 20 mg tablets daily for 5 days on, 2 days off (starting on Cycle 1 Day 1 of durvalumab), until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Cediranib

Intervention Type DRUG

Participants will receive oral tablets of cediranib as stated in arm description.

Module 8 Cohort A.8.ATM: Ceralasertib 240 mg

Participants who are ATM-deficient or with detectable aberrations in the ATM gene will receive oral ceralasertib (AZD6738) 240 mg tablets BD from Day 1 to Day 14 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 9 Cohort B.9.PRI: Durvalumab 1500 mg + Ceralasertib 240 mg

Participants who had anti-PD-1/PD-L1 containing therapy but had progression of disease within ≤ 24 weeks from the start of treatment (PRI) will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 9 Cohort B.9.ACQ: Durvalumab 1500 mg + Ceralasertib 240 mg

Participants who had progressive disease \> 24 weeks from the start of anti PD-1/PD-L1 containing therapy while still on that treatment (ACQ) will receive IV infusion of durvalumab 1500 mg Q4W plus oral ceralasertib (AZD6738) 240 mg tablets BD for 14 days from Day 15 to Day 28 of each 28-day cycle, until objective radiological disease progression, as long as, in the investigator's opinion, they were benefiting from treatment and did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 10 Cohort C.10.160: Durvalumab 1500 mg + Ceralasertib 160 mg

Participants, independent of their molecular aberration status, will receive oral ceralasertib (AZD6738) 160 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 160 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 10 Cohort C.10.240: Durvalumab 1500 mg + Ceralasertib 240 mg

Participants, independent of their molecular aberration status, will receive oral ceralasertib (AZD6738) 240 mg tablet BD for 7 days in Cycle 0 (Days 1 to 7). Thereafter, participants will receive IV infusion of durvalumab 1500 mg Q4W in combination with oral ceralasertib 240 mg tablet BD between Days 22 and 28 in each 28-day cycle, until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Module 11 Cohort C.11.240: AZD6738 240 mg

Participants, independent of their molecular aberration status, will receive oral AZD6738 tablet 240 mg for 7 days (Days 1 to 7) in each 28-day cycle until objective radiological disease progression, however, participants may continue treatment if benefiting from treatment in the investigator opinion or did not meet any other discontinuation criteria.

Group Type EXPERIMENTAL

Ceralasertib

Intervention Type DRUG

Participants will receive oral tablet of ceralasertib as stated in arm description.

Interventions

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Durvalumab

Participants will receive IV infusion of durvalumab as stated in arm description.

Intervention Type DRUG

Danvatirsen

Participants will receive IV infusion of danvatirsen as stated in arm description.

Intervention Type DRUG

Ceralasertib

Participants will receive oral tablet of ceralasertib as stated in arm description.

Intervention Type DRUG

Vistusertib

Participants will receive oral tablets of vistusertib as stated in arm description.

Intervention Type DRUG

Olaparib

Participants will receive oral tablets of olaparib as stated in arm description.

Intervention Type DRUG

Oleclumab

Participants will receive IV infusion of oleclumab as stated in arm description.

Intervention Type DRUG

Trastuzumab deruxtecan

Participants will receive IV infusion of trastuzumab deruxtecan as stated in arm description.

Intervention Type DRUG

Cediranib

Participants will receive oral tablets of cediranib as stated in arm description.

Intervention Type DRUG

Other Intervention Names

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AZD9150 AZD6738 T-DXd AZD2171

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age at the time of signing the informed consent form.
* Participant must have histologically or cytologically confirmed metastatic or locally advanced and recurrent non-small-cell lung cancer (NSCLC) which is progressing.
* Participants eligible for second- or later-line therapy, who must have received an anti-programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The participant must have had disease progression on a prior line of anti-PD-1/PD-L1 therapy.
* Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
* Participant must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed.
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants.

Exclusion Criteria

* Participants whose tumour samples have targetable alterations in epidermal growth factor receptor (EGFR) and/or anaplastic lymphoma kinase (ALK) at initial diagnosis are excluded. In addition, participants whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
* Active or prior documented autoimmune or inflammatory disorders.
* Active infection including tuberculosis, hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).
* Female participant who are pregnant or breastfeeding, or male or female participants of reproductive potential who are not willing to employ effective birth control.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients, or history of severe hypersensitivity reactions to other monoclonal antibodies.
* Participant has spinal cord compression or symptomatic brain metastases.
* Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Participants may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases.
* History of active primary immunodeficiency.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Heymach, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Locations

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Research Site

Duarte, California, United States

Site Status

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Fullerton, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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New York, New York, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Innsbruck, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Edmonton, Alberta, Canada

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Brampton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Nantes, , France

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Paris, , France

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Villejuif, , France

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Berlin, , Germany

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Esslingen a.N., , Germany

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Großhansdorf, , Germany

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Heidelberg, , Germany

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Haifa, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Seville, , Spain

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Countries

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United States Austria Canada France Germany Israel South Korea Spain

References

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Besse B, Pons-Tostivint E, Park K, Hartl S, Forde PM, Hochmair MJ, Awad MM, Thomas M, Goss G, Wheatley-Price P, Shepherd FA, Florescu M, Cheema P, Chu QSC, Kim SW, Morgensztern D, Johnson ML, Cousin S, Kim DW, Moskovitz MT, Vicente D, Aronson B, Hobson R, Ambrose HJ, Khosla S, Reddy A, Russell DL, Keddar MR, Conway JP, Barrett JC, Dean E, Kumar R, Dressman M, Jewsbury PJ, Iyer S, Barry ST, Cosaert J, Heymach JV. Biomarker-directed targeted therapy plus durvalumab in advanced non-small-cell lung cancer: a phase 2 umbrella trial. Nat Med. 2024 Mar;30(3):716-729. doi: 10.1038/s41591-024-02808-y. Epub 2024 Feb 13.

Reference Type DERIVED
PMID: 38351187 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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138050

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-509004-15-00

Identifier Type: OTHER

Identifier Source: secondary_id

2017-002208-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D6185C00001

Identifier Type: -

Identifier Source: org_study_id

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