Clinical trial 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 chemotherapy medicine being studied to help treat non-small cell lung cancer after surgery. It is designed to stop cancer cells from dividing and growing.
Also referred to as Paraplatin, Carbotec.
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
- The study aims to see if combining the drug pembrolizumab with usual chemotherapy can help patients live longer after their lung cancer has been removed by surgery.
- Who it's for
- It is looking for adults who have had surgery for stage IIA, IIB, IIIA, or IIIB non‑small cell lung cancer and are ready to start chemotherapy.
- What's involved
- Participants will receive the standard chemotherapy drugs (such as cisplatin, pemetrexed, carboplatin, gemcitabine, or paclitaxel) together with the immunotherapy drug pembrolizumab, following the same schedule as usual care.
- Time commitment
- The treatment period lasts several months, with regular clinic visits and blood tests to monitor progress and side effects.
- 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
- 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
See the full eligibility criteria
- 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).
- 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).
- 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.
- 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 is enrolling
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Jonesboro, Arkansas, United States
- Anaheim, California, United States
- Antioch, California, United States
- Auburn, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Berkeley, California, United States
- Dublin, California, United States
- Fontana, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Marysville, California, United States
+ 463 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, but 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?
This study is enrolling now at Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Jonesboro, Arkansas, United States; Anaheim, California, United States; Antioch, California, United States; Auburn, California, United States and 477 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.