Status:
ACTIVE_NOT_RECRUITING
Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer: AIM-HIGH (Adjuvant Intervention in Molecular High Risk Patients)
Lead Sponsor:
Razor Genomics
Collaborating Sponsors:
Encore Clinical
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after t...
Eligibility Criteria
Inclusion
- Written informed consent
- Age ≥ 18 years
- Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy according to local institutional standards and likely compliance with follow-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).
- Willing to be randomized to chemotherapy.
- Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per 8th edition, TNM staging system)
- Adequate tissue sample for the 14-Gene Prognostic Assay
- Life expectancy excluding NSCLC diagnosis ≥ 5 years
- ECOG performance status 0-1
Exclusion
- Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histologies
- Evidence of greater than stage IIA pathologic staging
- Evidence of incomplete resection
- Pregnant or lactating women
- Unwilling to use an effective means of contraception
- Active infection, either systemic or at site of primary resection
- Systemic chemotherapy or anti-cancer agent within 5 years prior to enrollment
- Radiotherapy to the chest in the immediate pre- or post- operative period
- Malignancies other than the current NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, non-melanoma skin cancer, localized prostate cancer treated locally, ductal carcinoma in situ treated surgically
- Treatment with any investigational drug or participation in another clinical trial within 28 days prior to enrollment
- Known hypersensitivity to study treatment agents
- Evidence of any other disease including infection that contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment-related complications
- Wound dehiscence or infection
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2027
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01817192
Start Date
September 11 2020
End Date
May 15 2027
Last Update
April 13 2025
Active Locations (49)
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1
Leonard Cancer Institute
Mission Viejo, California, United States, 92961
2
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Providence Medical Foundation Santa Rosa
Santa Rosa, California, United States, 95403
4
Sarah Cannon- FCS South
Fort Meyers, Florida, United States, 33916