Experimental Pembrolizumab Alone or Combined With Pemetrexed and Carboplatin For Advanced Non-Small Cell Lung Cancer (NSCLC)

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Advanced Nonsquamous Non-Small Cell Lung Cancer, NSCLC
Type: Drug study, Phase 3
Target:
6 Participants
Investigator:
Description
This study is being done to answer the following questions:

Does immunotherapy with MK-3475 (pembrolizumab) alone improve overall survival? This will be compared to combination therapy with chemotherapy, in patients with your type of cancer.

Does additional treatment with chemotherapy following immunotherapy alone also improve overall survival?

We are doing this study because we want to compare these two usual approaches to cancer treatment. The usual approach is defined as care most people get for PD-L1 positive non-squamous non-small cell lung cancer.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

INCLUSION CRITERIA

Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition). Patients with T4NX disease (Stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation.

Patients must have PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% in tumor cells. The assay must have been performed by a CLIA (or equivalent) certified laboratory.

Patients must have measurable or non-measureable disease as defined in Section 6.1.2. Presence of malignant pleural fluid alone is allowed as study eligibility. NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids. 3.1.4 Age ≥ 18 years. 3.1.5 Patients must have an ECOG Performance Status of 0 to 1

EXCLUSION CRITERIA Patients must NOT have received the following:

Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for lung cancer are ineligible. Chemotherapy for non-metastatic disease (e.g. adjuvant therapy) or immunotherapy for locally advanced Stage III disease is allowed if at least 6 months have elapsed since the prior therapy and registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 14 days has passed since completion.

Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.

Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.

Patients with symptomatic brain metastases are excluded. Patients with treated or asymptomatic brain metastases are eligible if off steroids for at least 14 days prior to protocol treatment. Anticonvulsants are allowed.

Patients with another active malignancy within the last 2 years are excluded. Adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years are permitted.

Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn’s disease, malabsorption, etc.)

Patients must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Patients must not have history of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, NYHA classification of 3, unstable angina or poorly controlled arrhythmia, or myocardial infarction within 6 months prior to registration.

Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug.

Patients must not receive any other investigational agents during the course of therapy.

Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK-3475 (pembrolizumab). Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.

Patients must have adequate liver function

Patients must not have a known history of active tuberculosis (TB).

Patients must not have a diagnosis of immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol treatment.

Patients must not have received a live vaccine within 30 days prior to randomization. Seasonal flu vaccines that do not contain live virus are permitted.

Patients who are known to be Human Immunodeficiency Virus (HIV) positive are eligible if they meet the following eligibility requirements:

They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective.

They must have a CD4+ T-cell count 250 cells/mcL.

They must not be receiving prophylactic therapy for an opportunistic infection.

Patients must not have known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected).

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be in the study until your disease gets worse, the side effects become too severe, or for up to 2 years of treatment.
Recruitment period
From March 26, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Lung Non-Squamous Non-Small Cell Carcinoma
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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