Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: BI 836845; Drug: afatinib

• Registration Number: NCT02191891
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Part A: To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of Xentuzumab (BI 836845) in combination with afatinib in patients with non-small cell lung cancer with progression following prior treatment (EGFR TKI or platinum-based chemotherapy).

Part B: To evaluate the early anti-tumour activity of Xentuzumab (BI 836845) in combination with afatinib in patients with EGFR mutant non-small cell lung cancer with progression following prior irreversible EGFR TKIs.

Part A and B: To evaluate the safety and pharmacokinetics of BI 836845 in combination with afatinib in patients with non-small cell lung cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Study Start: 2014-10-21
• Status Verified: 2018-04
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 836845 + afatinib	BI 836845	BI 836845 low or high dose (weekly IV infusion), afatinib 30mg or 40mg (once daily oral dosing)
BI 836845 + afatinib	afatinib	BI 836845 low or high dose (weekly IV infusion), afatinib 30mg or 40mg (once daily oral dosing)

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of BI 836845 in combination with afatinib - part A	up to 12 months
Dose limiting toxicity (DLT) during the first treatment course - part A	up to 28 days
Objective response (OR), defined as complete response (CR) or partial response (PR)	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Disease control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD)	up to 12 months
Time to objective response, defined as the duration of time from the date of first treatment administration until objective response	up to 12 months
Duration of objective response, defined as the duration of time from first objective response to the date of first objective tumour progression or death due to any cause	up to 12 months

Trial Locations

Locations (10)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka, Fukuoka, Japan

National Cancer Centre; 🇸🇬 Singapore, Singapore

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chang Gung Memorial Hospital Chiayi; 🇨🇳 Chiayi, Taiwan

NCKUH; 🇨🇳 Tainan, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan