2022-501987-16-00招募中3 期
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 (POD1UM-304)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- OS, defined as the time from randomization until death due to any cause..
研究概览
简要总结
To compare the OS of the combinations of INCMGA00012 and chemotherapy versus placebo and chemotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Has adequate organ function as indicated by the laboratory values in Table
- •Specimens must be collected and reviewed within 10 days prior to the start of study treatment.
- •Has had an evaluation by the investigator regarding vaccination against SARS-CoV-2 before study entry. Note: Vaccination before study entry is a strong recommendation, not a requirement. Potential participants and the investigator should discuss up-to-date information according to national or local vaccination programs and/or oncology professional guidelines.
- •Is at least 18 years of age on the day of signing the ICF (or as applicable per local country requirements)
- •Has histologically or cytologically confirmed diagnosis of NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8). a. Documentation for absence of driver mutations or gene rearrangements for EGFR, ALK, BRAF, and ROS1 if the tumor is of nonsquamous histology. Note: If documentation does not exist for all 4 driver mutations, then archived or fresh tumor tissue material must be tested locally, or centrally arranged by the sponsor. Detailed information is found in the Laboratory Manual. b. If participant's tumor is known to have a predominantly squamous histology, molecular testing for EGFR mutation, ALK, BRAF, and ROS1 translocations will not be required, as this is not part of current diagnostic guidelines. c. Tumor with mixed histology will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. In cases where it is not completely known, testing must occur.
- •No prior systemic treatment for the advanced/metastatic NSCLC with the exception of neoadjuvant or adjuvant therapy that did not include a PD-(L)1 directed therapy and completed at least 12 months before the development of metastatic disease. Note: Only participants without access (due to inadequate reimbursement, labelling restrictions, or any other reason) to the best standard treatment options (eg, an approved PD-(L)1 inhibitor in combination with chemotherapy or monotherapy) that, according to the investigator, could benefit the participant more can be included in the study. If the best approved and reimbursed standard treatment options become available during the study, the participant may discontinue from study treatment if the investigator and the participant believe that the participant could benefit more by switching to the approved and reimbursed standard treatment.
- •Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy after a participant has been diagnosed with metastatic disease, for central confirmation of PD-L1 status. Note: Biopsy should be from a tumor site that has not been treated with radiation. Formalin-fixed archival specimens after the participant has been diagnosed with metastatic disease will be preferred for determination of PD-L1 status (and driver mutations if needed) prior to randomization
- •Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Has an ECOG performance status of 0 or 1 at study entry
- •Has a life expectancy of at least 3 months before signing the ICF
- •Willingness to avoid pregnancy or fathering children based on the criteria below: a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 180 days after the last dose of chemotherapy and 120 days after the last dose of INCMGA00012 and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed. b. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: − Women of childbearing potential must have a negative pregnancy test at screening (within 72 hours of the first dose on Day 1). Women of childbearing potential must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 180 days after the last dose of chemotherapeutic agents and for at least 120 days after the last dose of INCMGA
- •Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed. − Women of nonchildbearing potential (see Appendix A for definitions) are eligible.
排除标准
- •Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions is eligible
- •Has known active HBV or HCV as defined in protocol
- •Has a known history of HIV infection. HIV testing is not required unless mandated by the local health authority, or local regulations
- •Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 3 years since initiation of that therapy
- •Has had an allogeneic tissue/solid organ transplant
- •Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity to any component of INCMGA00012 or as applicable, to carboplatin, cisplatin, paclitaxel, nab-paclitaxel, or pemetrexed.
- •Is unable to interrupt aspirin or other NSAIDS, other than an aspirin dose ≤ 1.3 g per day, for a 5-day period (8-day period for long acting agents)
- •Is unable or unwilling to take folic acid or vitamin B12 supplementation
- •Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg,thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
- •Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication. a. Corticosteroid use after randomization is allowed for management of AEs, SAEs, as a premedication for IV contrast, or if considered necessary for a participant's welfare. b. Participants who receive daily steroid replacement therapy ≤ 10 mg prednisone or equivalent are exempt. c. Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate (are allowed to participate). d. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate
- •Received prior systemic cytotoxic chemotherapy, targeted or biological therapy for metastatic disease therapy with an anti–PD-1/PDL1/PD-L2, anti-CD137, or anticytotoxic T-lymphocyte–associated antigen-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- •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). a. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine
- •Current use of any prohibited medication as described in Section 6.6.3
- •Has a history or current evidence of any condition including psychiatric or substance abuse disorders, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's ability to participate, or cooperate, for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •Has clinically significant or impaired cardiac disease including acute myocardial infarction, unstable angina, or New York Heart Association Class III or IV CHF within 6 months before study Day
- •Has other clinically significant heart disease (ie, ≥ uncontrolled Grade 3 hypertension) before study Day
- •Medically controlled arrhythmia stable on medication for at least 14 days before study Day 1 is permitted.
- •Had any major surgery within 3 weeks of the first dose of study treatment.
- •Received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study treatment.
- •Has a history of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel
- •Has untreated CNS metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified before signing the ICF
- •Evidence of interstitial lung disease or history of interstitial lung disease, or has history of noninfectious pneumonitis that required systemic steroids or has active pneumonitis.
- •Has an active infection requiring IV systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS-CoV-2 infection until both the retesting result is negative and clinical recovery is obtained
结局指标
主要结局
OS, defined as the time from randomization until death due to any cause..
OS, defined as the time from randomization until death due to any cause..
次要结局
- PFS, defined as the time from randomization until disease progression by RECIST v1.1 as determined by BICR or death due to any cause.
- ORR, defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 based on BICR.
- DOR, defined as the time from the earliest date of documented response until earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR.
- Number of participants experiencing AEs and number of participants discontinuing study drug due to AEs.
- Population PK parameters (including Cmax, AUC) will be summarized.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (5)
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