A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants - Ph2 Platform Trial of Novel Regimens vs. SoC in NSCLC

GlaxoSmithKline Research and Development Ltd.0 sites105 target enrollmentJanuary 25, 2019

Conditionsnon-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsDocetaxel

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: non-small cell lung cancer (NSCLC)
Sponsor: GlaxoSmithKline Research and Development Ltd.
Enrollment: 105
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 25, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research and Development Ltd.

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all the following criteria apply:
•1\. Capable of giving signed informed consent/assent as described in Section 12\.4 of protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
•2\. Male or female, aged 18 years or older at the time consent is obtained
•Note: Participants in Korea must be age 19 years or older at the time consent is obtained.
•3\. Histologically or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous)
•a. Documented disease progression (for example, based on radiographic imaging) during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IV or metastatic disease:
•i. A maximum of 1 line of platinum\-containing chemotherapy regimen in the metastatic setting, and ii. A maximum of 1 line of PD(L)1 mAb containing regimen.
•o PD(L)1 mAb received during a previous clinical trial may meet this requirement upon consultation with study medical monitor.
•o Participants on the phase III PACIFIC trial (NCT02125461\) experimental regimen (chemoradiotherapy followed by durvalumab) \[Antonia, 2017] or received the PACIFIC regimen \[chemoradiotherapy followed by PD(L)1] as part of SoC AND have relapsed within one year from the first dose of chemoradiotherapy would fulfill the protocol requirement for platinum\-based chemotherapy treatment and PD\-1 treatment.
•This would be considered a single line of treatment for the purpose of PD(L)1 line of therapy stratification.

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•1\. Received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
•a. Docetaxel at any time
•b. Any of the investigational agents being tested in the current study, including experimental ICOS agonist
•c. Systemic approved or investigational anticancer therapy within 30 days or 5 half\-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
•d. Prior radiation therapy: permissible if at least one non\-irradiated measurable lesion is available for assessment per RECIST version 1\.1
•or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
•2\.Received \>2 prior lines of therapy for NSCLC, including participants with BRAF molecular alterations. (See inclusion criterion \#3 for eligible lines of therapy guidance)
•Note: Patients with known EGFR/ALK/ROS1 molecular alterations are excluded from participation in this study.
•3\. Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except as noted below: