BridgeMD
New treatment option for Lung Non-Small Cell Carcinoma
Official title 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])
ClinicalTrials.gov ID: NCT04267848
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung non-small cell carcinoma.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Gilbert, Arizona, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Jonesboro, Arkansas, United States
- Anaheim, California, United States
- Antioch, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Berkeley, California, United States
- Burbank, California, United States
- Burlingame, California, United States
- Cameron Park, California, United States
+ 731 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Gilbert, Arizona, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Sun City, Arizona, United States and 745 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.