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)

Razor Genomics

Status: Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: 14-Gene Prognostic Assay; Drug: Adjuvant Chemotherapy; Other: Radiographic surveillance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01817192

EC-120888

IFCT-2002 (Other Identifier)

Details and patient eligibility

About

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 the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Observation

Active Comparator group

Description:

Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.

Treatment:

Other: Radiographic surveillance

Other: 14-Gene Prognostic Assay

Adjuvant Chemotherapy

Active Comparator group

Description:

Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.

Treatment:

Drug: Adjuvant Chemotherapy

Other: 14-Gene Prognostic Assay