A Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • sponsor
    Bristol-Myers Squibb
Updated on 24 November 2020
cancer
systemic therapy
measurable disease
lung cancer
EGFR
nivolumab
cancer chemotherapy
stage iv non-small cell lung cancer
lung carcinoma
non-small cell carcinoma

Summary

A Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Description

The purpose of this research study is to see if nivolumab and ipilimumab in combination with chemotherapy is better at improving survival when compared to standard chemotherapy treatment. This study will also test the effectiveness (how well the drug works), safety, and tolerability of the nivolumab and ipilimumab combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Details
Condition Non-Small Cell Lung Cancer
Clinical Study IdentifierTX151355
SponsorBristol-Myers Squibb
Last Modified on24 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Signed Written Informed Consent
Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal patient care
Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
Type of Participant and Target Disease Characteristics
ECOG Performance Status of ≤ 1
Participants must have a life expectancy of at least 3 months
Histologically confirmed stage IV NSCLC per the 7th International Association for the Study of Lung Cancer classification (IASLC)43 of squamous or non-squamous histology, with no prior systemic anti-cancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease
Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (which ever was given last) occurred at least 6 months prior to enrollment. Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative options), is eligible to enroll
Prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment
Measurable disease by CT or MRI per RECIST 1.1 criteria (Appendix 7); radiographic tumor assessment performed within 28 days before treatment
Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site after the completion of radiation therapy
Participants are to have tumor tissue sample available at a central laboratory for PD-L1 IHC testing during the screening period. Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or 15 unstained tumor tissue sections, with an associated pathology report, must be submitted for biomarker evaluation prior to treatment. The tumor tissue sample may be fresh or archival, (archival tissue is to be obtained within 3 months prior to enrollment), and there can have been no systemic therapy (eg, adjuvant or neoadjuvant chemotherapy) given after the sample was obtained. Tissue must be from a core needle biopsy, excisional or incisional biopsy. Fine needle biopsies or drainage of pleural effusions with cytospins are not considered adequate for biomarker review. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumor samples are also not acceptable
Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period
Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment
Screening laboratory values must meet the following criteria (using CTCAE v4)
WBC ??2000/µL
Neutrophils ??1500/µL
Platelets ??100 x 103/µL
Hemoglobin ??9.0 g/dL
Serum creatinine ??1.5 x ULN or calculated creatinine clearance ??50 mL/min 1(using the Cockcroft Gault formula) Female CrCl = (140 - age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00/ 72 x serum creatinine in mg/dL
AST/ALT ??3.0 x ULN (??5 x ULN if liver metastases are present)
Total bilirubin ?1.5 x ULN except subjects with Gilbert Syndrome who must have a total bilirubin level > 3.0 mg/dL). Subject Re-enrollment: This study permits the re-enrollment of a subject who has discontinued the study as a pre-treatment failure (ie, subject has not been treated). If re-enrolled, the subject must be re-consented
Age and Reproductive Status
Males and Females, ages ≥ 18 years of age
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
Women must not be breastfeeding
WOCBP must agree to follow instructions for methods(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of nivolumab (ie 30 days [duration of ovulatory cycle] plus the time required for nivolumab to undergo approximately five half-lives)
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and up to 7 months after the last dose of nivolumab (ie 90 days [duration of sperm turnover] plus the time required for nivolumab to undergo approximately five half-lives)

Exclusion Criteria

Medical Conditions
Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded. All participants with non-squamous histology must have been tested for EGFR mutation status. EGFR test is to be done locally. EGFR test is not provided by a third party laboratory. Use of a FDA-approved test (PCR based assay from tumor tissue) is strongly encouraged. Tests other than PCR or next generation sequencing will be requested to repeat using PCR or next generation sequencing based methods. Participants of non-squamous histology with unknown or indeterminate EGFR status are excluded
Participants with known ALK translocations which are sensitive to available targeted inhibitor therapy are excluded. If tested, use of an FDA-approved test is strongly encouraged. Participants with unknown or indeterminate ALK status may be enrolled
Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of = 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first treatment
Participants with carcinomatous meningitis
Participants must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before first treatment
Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period
Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Testing for HIV must be performed at sites mandated by local requirements
Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
Prior/Concomitant Therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Physical and Laboratory Test Findings
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Participants with ≥ Grade 2 peripheral neuropathy
Allergies and Adverse Drug Reaction
History of allergy or hypersensitivity to study drug components
Other Exclusion Criteria
Prisoners or participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required
Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a participant's ability to comply with the study requirements, substantially increase risk to the participant, or impact the interpretability of study results
Participants with a history of screen failure to any anti-PD-1 or anti-PD-L1 antibody clinical trial due to PD-L1 negative status. Eligibility criteria for this study have been carefully considered to ensure the safety of the study participants and that the results of the study can be used. It is imperative that participants fully meet all eligibility criteria
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