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])
Recruiting · NCT04267848 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionCarboplatinCisplatinComputed TomographyEchocardiography TestGemcitabine HydrochlorideMagnetic Resonance ImagingObservation ActivityPaclitaxelPembrolizumabPemetrexed DisodiumQuestionnaire Administration
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
60 locations listed across 49 US states.
- Anchorage Associates in Radiation Medicine - Anchorage, Alaska, United States
- Anchorage Radiation Therapy Center - Anchorage, Alaska, United States
- Alaska Breast Care and Surgery LLC - Anchorage, Alaska, United States
- Alaska Oncology and Hematology LLC - Anchorage, Alaska, United States
- Alaska Women's Cancer Care - Anchorage, Alaska, United States
- Anchorage Oncology Centre - Anchorage, Alaska, United States
- Katmai Oncology Group - Anchorage, Alaska, United States
- Providence Alaska Medical Center - Anchorage, Alaska, United States
- Fairbanks Memorial Hospital - Fairbanks, Alaska, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Kingman Regional Medical Center - Kingman, Arizona, United States
- Cancer Center at Saint Joseph's - Phoenix, Arizona, United States
- Banner Boswell Medical Center - Sun City, Arizona, United States
- Banner University Medical Center - Tucson - Tucson, Arizona, United States
- University of Arizona Cancer Center-North Campus - Tucson, Arizona, United States
- Mercy Hospital Fort Smith - Fort Smith, Arkansas, United States
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs, Arkansas, United States
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro, Arkansas, United States
- Kaiser Permanente-Anaheim - Anaheim, California, United States
- Kaiser Permanente-Deer Valley Medical Center - Antioch, California, United States
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande, California, United States
- PCR Oncology - Arroyo Grande, California, United States
- Sutter Auburn Faith Hospital - Auburn, California, United States
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn, California, United States
- Kaiser Permanente-Baldwin Park - Baldwin Park, California, United States
- Kaiser Permanente-Bellflower - Bellflower, California, United States
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley, California, United States
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank, California, United States
- Mills-Peninsula Medical Center - Burlingame, California, United States
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park, California, United States
- Eden Hospital Medical Center - Castro Valley, California, United States
- John Muir Medical Center-Concord - Concord, California, United States
- Sutter Davis Hospital - Davis, California, United States
- City of Hope Comprehensive Cancer Center - Duarte, California, United States
- Epic Care-Dublin - Dublin, California, United States
- Kaiser Permanente Dublin - Dublin, California, United States
- Bay Area Breast Surgeons Inc - Emeryville, California, United States
- Epic Care Partners in Cancer Care - Emeryville, California, United States
- Kaiser Permanente-Fontana - Fontana, California, United States
- Kaiser Permanente-Fremont - Fremont, California, United States
- Palo Alto Medical Foundation-Fremont - Fremont, California, United States
- Kaiser Permanente Fresno Orchard Plaza - Fresno, California, United States
- Kaiser Permanente-Fresno - Fresno, California, United States
- Kaiser Permanente South Bay - Harbor City, California, United States
- Kaiser Permanente-Irvine - Irvine, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Loma Linda University Medical Center - Loma Linda, California, United States
- Tibor Rubin VA Medical Center - Long Beach, California, United States
- Kaiser Permanente Los Angeles Medical Center - Los Angeles, California, United States
- Kaiser Permanente West Los Angeles - Los Angeles, California, United States
- Contra Costa Regional Medical Center - Martinez, California, United States
- Fremont - Rideout Cancer Center - Marysville, California, United States
- Memorial Medical Center - Modesto, California, United States
- Kaiser Permanente- Modesto MOB II - Modesto, California, United States
- Kaiser Permanente-Modesto - Modesto, California, United States
- Palo Alto Medical Foundation-Camino Division - Mountain View, California, United States
- Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View, California, United States
- Alta Bates Summit Medical Center - Summit Campus - Oakland, California, United States
- Bay Area Tumor Institute - Oakland, California, United States
- Kaiser Permanente Oakland-Broadway - Oakland, California, United States
Showing 60 of 1151 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →