Recruiting
Phase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Condition(s) studied
Lung Non-Small Cell CarcinomaLung Non-Small Cell Squamous CarcinomaLung Non-Squamous Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8
Investigational drug(s) / intervention(s)
Biospecimen Collection: Undergo blood sample collection
Carboplatin: Given IV
Cisplatin: Given IV
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Gemcitabine Hydrochloride: Given IV
Magnetic Resonance Imaging: Undergo MRI
Observation Activity: Undergo observation
Paclitaxel: Given IV
Pembrolizumab: Given IV
Pemetrexed Disodium: Given IV
Questionnaire Administration: Ancillary studies
Study summary
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.
Eligibility
Inclusion Criteria:
* A female of childbearing potential is a sexually mature female who:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
* Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
* Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263
* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017
* Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population
* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
* No prior allogeneic tissue/solid organ transplant
* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required
* No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
* No hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
* No known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8 gm/dl
* Calculated (Calc.) creatinine clearance \>= 45 mL/min
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
Primary outcome measure(s)
- Disease free survival (DFS) — From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion
Will compare DFS between the two arms (combination versus sequential pembrolizumab added to standard of care platinum-based adjuvant therapy) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. Will be estimated using the Kaplan-Meier method, where the stratified log-rank test (using the central PD-L1 result for the PD-L1 expression status) will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors (using the central PD-L1 result for the PD-L1 expression status) used in the randomization will be assessed as well.
Trial sites (1151)
| Facility | City | Region | Status |
| Anchorage Associates in Radiation Medicine |
Anchorage |
Alaska |
Suspended |
| Anchorage Radiation Therapy Center |
Anchorage |
Alaska |
Suspended |
| Alaska Breast Care and Surgery LLC |
Anchorage |
Alaska |
Suspended |
| Alaska Oncology and Hematology LLC |
Anchorage |
Alaska |
Suspended |
| Alaska Women's Cancer Care |
Anchorage |
Alaska |
Suspended |
| Anchorage Oncology Centre |
Anchorage |
Alaska |
Suspended |
| Katmai Oncology Group |
Anchorage |
Alaska |
Suspended |
| Providence Alaska Medical Center |
Anchorage |
Alaska |
Suspended |
| Fairbanks Memorial Hospital |
Fairbanks |
Alaska |
Recruiting |
| Banner MD Anderson Cancer Center |
Gilbert |
Arizona |
Suspended |
| Kingman Regional Medical Center |
Kingman |
Arizona |
Suspended |
| Cancer Center at Saint Joseph's |
Phoenix |
Arizona |
Suspended |
| Banner Boswell Medical Center |
Sun City |
Arizona |
Recruiting |
| Banner University Medical Center - Tucson |
Tucson |
Arizona |
Active Not Recruiting |
| University of Arizona Cancer Center-North Campus |
Tucson |
Arizona |
Active Not Recruiting |
| Mercy Hospital Fort Smith |
Fort Smith |
Arkansas |
Suspended |
| CHI Saint Vincent Cancer Center Hot Springs |
Hot Springs |
Arkansas |
Suspended |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro |
Jonesboro |
Arkansas |
Recruiting |
| Kaiser Permanente-Anaheim |
Anaheim |
California |
Recruiting |
| Kaiser Permanente-Deer Valley Medical Center |
Antioch |
California |
Recruiting |
| Mission Hope Medical Oncology - Arroyo Grande |
Arroyo Grande |
California |
Suspended |
| PCR Oncology |
Arroyo Grande |
California |
Suspended |
| Sutter Auburn Faith Hospital |
Auburn |
California |
Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Auburn |
Auburn |
California |
Suspended |
| Kaiser Permanente-Baldwin Park |
Baldwin Park |
California |
Recruiting |
| Kaiser Permanente-Bellflower |
Bellflower |
California |
Recruiting |
| Alta Bates Summit Medical Center-Herrick Campus |
Berkeley |
California |
Recruiting |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center |
Burbank |
California |
Suspended |
| Mills-Peninsula Medical Center |
Burlingame |
California |
Suspended |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park |
Cameron Park |
California |
Suspended |
| Eden Hospital Medical Center |
Castro Valley |
California |
Suspended |
| John Muir Medical Center-Concord |
Concord |
California |
Active Not Recruiting |
| Sutter Davis Hospital |
Davis |
California |
Suspended |
| City of Hope Comprehensive Cancer Center |
Duarte |
California |
Active Not Recruiting |
| Epic Care-Dublin |
Dublin |
California |
Active Not Recruiting |
| Kaiser Permanente Dublin |
Dublin |
California |
Recruiting |
| Bay Area Breast Surgeons Inc |
Emeryville |
California |
Active Not Recruiting |
| Epic Care Partners in Cancer Care |
Emeryville |
California |
Active Not Recruiting |
| Kaiser Permanente-Fontana |
Fontana |
California |
Recruiting |
| Kaiser Permanente-Fremont |
Fremont |
California |
Recruiting |
+ 1111 more sites — see the full list on the official registry below.
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