The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

• Status: Recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. This trial will be offered to patients who are previously untreated for stage IV NSCLC.

The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior outcome in elderly patients with untreated, advanced NSCLC compared to standard of care treatments (arm B, the standard arm).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Carboplatin; Docetaxel; Gemcitabine; Pemetrexed; Vinorelbine

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed NSCLC.

• Stage IV NSCLC by the AJCC Staging Manual 7th edition (2010).

• Measurable or evaluable disease by RECIST 1.1.

• Age equal or more than 70 years.

• Performance Status 0 or 1 (by ECOG criteria).

• Adequate bone marrow function.

• Signed informed consent document (ICD).

• Men with partners in the childbearing age group must use effective contraception.

• Previous surgery for NSCLC (more than 30 days before study registration) is allowed.

• Previous radiotherapy is allowed if: the time between completion of RT and initiation of study treatment is at least 7 days,the patient has fully recovered from all toxic effects, and at least one target lesion or evaluable disease is outside the radiation field.

• Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a curative intent surgical resection for a NSCLC. Patient should be previously untreated for metastatic disease.

• Patients with stable brain metastases will be allowed to enroll. Stable brain metastasis is defined as no progression of brain metastases 14 days after conclusion of definitive treatment as documented by a CT scan or MRI of the brain.

Exclusion Criteria:

• Prior systemic chemotherapy or immunotherapy for advanced NSCLC.

• Prior malignancies, except: cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or any other curatively treated malignancy with no evidence of disease recurrence for at least 2 years.

• Presence of uncontrolled brain or leptomeningeal metastases.

• Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v 4.0 except if due to trauma.

• Other serious illness or medical condition, including but not limited to: congestive heart failure;myocardial infarction within 6 months;significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician; infection requiring I.V. antibiotics; tuberculosis with ongoing therapy at study entry, superior vena cava syndrome, except if controlled with radiation, active peptic ulcer disease; unstable diabetes mellitus;any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease.

• Hypercalcemia requiring therapeutic intervention.

• Clinically significant ascites and/or pericardial effusion.

• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

• Concurrent treatment with other investigational drugs.

• Patients known to harbor sensitizing EGFR mutations in exons 18, 19 and 21. Patients with resistance mutation in exon 20 will be allowed to enroll i.e. T790M and D770. The rare patient who has both a resistance mutation and a sensitizing mutation at the diagnoses will be excluded in the protocol.

• Patients whose tissue submission is not of adequate size to perform molecular testing will be excluded.

• Patients known to have translocations of ALK will also be excluded; however, testing for ALK translocation prior to study entry is not mandated.