A Phase II Study of Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA) Big Ten Cancer Research Consortium BTCRC-LUN19-396

Who is this study for? Patients with stage I, IIA, IIB, and select IIIA resected non-small cell lung cancer and the clearance of circulating tumor DNA
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The vast majority of patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC are managed with upfront surgery, followed by adjuvant chemotherapy. However, relapse rates remain high and are primarily due to distant, metastatic disease. Previous meta-analysis evaluating the use of neo-adjuvant chemotherapy and adjuvant chemotherapy demonstrate a similar impact on improved disease free survival (DFS) and overall survival (OS). The role of checkpoint inhibitors has been proven to be effective in the treatment of patients with advanced NSCLC, regardless of histology and PD-L1 expression. Results from trials evaluating the use of checkpoint inhibitors alone or in combination with chemotherapy in the neoadjuvant setting for early stage disease are promising. However, there are no trials evaluating the role of concomitant chemotherapy and checkpoint inhibitors in the adjuvant setting. In addition, emerging data supports the use of ctDNA as a promising biomarker for early detection of minimal residual disease and have indicated that the presence of detectable ctDNA after surgery for localized lung cancer is correlated with a 90-100% chance for disease recurrence. Therefore, we propose this current study assessing concomitant chemotherapy plus Atezolizumab in the adjuvant setting for patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC who have detectable ctDNA after surgery. The clearance of ctDNA will serve as a surrogate for long term DFS and OS in this patient population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

• Age \>= 18 years at the time of consent.

• ECOG Performance Status of 0-1 within 28 days prior to registration.

• Patients must have undergone complete surgical resection of their stage I (tumors \>= 4cm), IIA, IIB, and select stage III \[any T1-3 N1-2 and T4N0-2\] NSCLC according to the AJCC 8th edition with negative margins (R0).

• Squamous or non-squamous NSCLC histology. Cancers with a histology of adenosquamous are considered a type of adenocarcinoma and thus non-squamous histology.

• Surgery for this lung cancer must be completed \<= 60 days prior to starting treatment.

• Must have tissue available to perform prospective correlative testing. Tissue block is preferred but 10-15 unstained slides (5 μm thick) are also acceptable. If prior PD-L1 results with Dako 22C3 antibody are not available, an additional 5 unstained slides (4 μm thick) must be submitted.

• Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.

• Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:

‣ Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab.

⁃ A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\> or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.

⁃ Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

⁃ The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.

• Contraception method must begin starting from the time of informed consent until 5 months after treatment discontinuation.

• For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:

‣ With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 5 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.

⁃ The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.

• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

Locations
United States
Arizona
Banner MD Anderson Cancer Center
WITHDRAWN
Gilbert
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Indiana
Indiana University Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
New Jersey
Summit Health
RECRUITING
Berkeley Heights
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
New York University Clinical Cancer Center
RECRUITING
New York
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Pennsylvania
Penn State Cancer Institute
RECRUITING
Hershey
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Nasser Hanna, MD
nhanna@iu.edu
317-944-0920
Backup
Thao Nguyen
tnguyen@hoosiercancer.org
317-634-5842
Time Frame
Start Date: 2020-05-22
Estimated Completion Date: 2026-01
Participants
Target number of participants: 100
Treatments
Experimental: NSC: Non-squamous cell tumors
Atezolizumab 1200mg, Pemetrexed 500 mg/m\^2, Cisplatin 60-75 mg/m\^2
Experimental: SC: Squamous cell tumors
Atezolizumab 1200mg, Docetaxel 60-75 mg/m\^2, Cisplatin 60-75 mg/m\^2
Authors
Jyoti Malhotra, Ticiana Leal, Patrick Ma
Sponsors
Collaborators: Genentech, Inc.
Leads: Nasser Hanna

This content was sourced from clinicaltrials.gov

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