Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: cetuximab; Drug: cisplatin; Drug: docetaxel; Radiation: Radiotherapy; Procedure: Surgery

• Registration Number: NCT01059188
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see how well it works in treating patients with stage IIIB non-small cell lung cancer that can be removed by surgery.

Detailed Description

OBJECTIVES:

* To evaluate the efficacy and safety of neoadjuvant sequential chemoimmunotherapy comprising cetuximab, cisplatin, and docetaxel before radiotherapy and cetuximab followed by surgery in patients with resectable stage IIIB non-small cell lung cancer.

OUTLINE: This is a multicenter study.

* Chemoimmunotherapy (courses 1-3): Patients receive chemoimmunotherapy comprising cetuximab IV over 1-2 hours on days 1, 8, and 15; cisplatin IV over 1 hour on days 1 and 2; and docetaxel IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) on days 3-8 or a single dose of pegfilgrastim the day after chemotherapy. Treatment repeats every 3 weeks for 3 courses.

* Radiotherapy (course 4): Beginning on day 1 of week 10, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy 5 days a week for 3 weeks. Patients also receive cetuximab IV over 1 hour on days 1, 8, and 15.

* Surgery: Beginning 21-28 days after completion of radiotherapy, patients undergo surgery.

After completion of study treatment, patients are followed every 3 months for 2 years and every 6 months for 3 years.

Study Timeline

• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Study Start: 2010-05-03
• Primary Completion: 2016-12-09
• Status Verified: 2022-03
• Study Completion: 2022-03-08
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery	Surgery	-
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery	Radiotherapy	-
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery	cisplatin	-
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery	cetuximab	-
Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery	docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	at 1 year (+/- 1 month)

Secondary Outcome Measures

Name	Time	Method
Treatment-related death during chemoimmunotherapy, radioimmunotherapy, and perioperatively	30 days after surgery
Metabolic response evaluated by PET	At baseline and after chemo-immunotherapy
Complete pathological response	After surgery
Response status after chemoimmunotherapy and radioimmunotherapy	After chemoimmunotherapy and after radioimmunotherapy
Operability	Before trial treatment
Overall survival	At the end of the follow-up phase (max. 5 years after treatment termination or surgery)
Adverse events	During the all trial treatment until 30 days after surgery or treatment stop

Trial Locations

Locations (15)

Regionalspital; 🇨🇭 Thun, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Hopital Fribourgeois; 🇨🇭 Fribourg, Switzerland

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Saint Claraspital AG; 🇨🇭 Basel, Switzerland

Kantonsspital Bruderholz; 🇨🇭 Bruderholz, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland

Kantonsspital Liestal; 🇨🇭 Liestal, Switzerland