A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non–Small Cell Lung Cancer.

  • STATUS
    Recruiting
Updated on 14 December 2020
cancer
measurable disease
lung cancer
cancer chemotherapy
platinum-based chemotherapy
lung carcinoma
non-small cell carcinoma

Summary

The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non–small cell lung cancer (NSCLC).

Description

For more information, please contact Incyte Corporation at +1 (855) 463-3463.

Details
Condition Non-Small Cell Lung Cancer, Lung Cancer
Clinical Study IdentifierTX249870
Last Modified on14 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Non-Small Cell Lung Cancer or Lung Cancer?
Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8)
No prior systemic treatment for the advanced/metastatic NSCLC
Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy
Measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Willingness to avoid pregnancy or fathering children
Adequate organ function as indicated by protocol-specified laboratory values

Exclusion Criteria

Clinically significant cardiac disease within 6 months of start of study treatment
Any major surgery within 3 weeks of the first dose of study treatment
Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study treatment
History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel
Untreated central nervous system metastases and/or carcinomatous meningitis
Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids
Active infection requiring systemic therapy or active tuberculosis
Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers
Has contraindications to chemotherapy agents used in the study
Has an active autoimmune disease that has required systemic treatment in past 2 years
Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment
Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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