Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC (NCT02716038) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC
United States39 participantsStarted 2016-06-07
Plain-language summary
This is a research study to test the effectiveness of nab-paclitaxel + carboplatin + MPDL3280A for treatment of non-small-cell lung carcinoma (NSCLC), which is a type of lung cancer. The study aims to determine if chemotherapy combined with immune-based therapy can lead to improvement in tumor response rates over historical response rates with chemotherapy alone.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have pathologically confirmed non-small cell lung cancer, of either squamous or non-squamous histology.
* Stage 1B-3A
* Deemed surgically resectable by a thoracic surgeon
* Age ≥ 18 years
* Radiologically measurable disease, as defined by response evaluation criteria in solid tumours (RECIST) v1.1
* Ability to understand and the willingness to sign a written informed consent document
* Females of child-bearing potential must:
* Either commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception (\</=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 90 days following treatment completion.
* Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.
* Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at lea…
What they're measuring
1
Number of Subjects With Major Pathologic Response (MPR)