Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients

Betta Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: Chemotherapy; Drug: Icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01843647

BD-IC-IV06

Details and patient eligibility

About

The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Full description

Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.

  3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.

  4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.

Exclusion criteria

• 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Icotinib

Experimental group

Description:

Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.

Treatment:

Drug: Icotinib

Chemotherapy

Active Comparator group

Description:

Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.

Treatment:

Drug: Chemotherapy