Trial Outcomes & Findings for Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001 (NCT NCT03574818)

Last Updated: 2020-03-18

Results Overview

Patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting with gemcitabine and cisplatin in surgically resectable patients with stage IB with tumor size \>4cm, II and potentially resectable IIIA squamous cell lung cancer.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

up to 63 days

Results posted on

2020-03-18

Participant Flow

one patient was enrolled in May 2018, study was terminated in September 2019 due to poor accrual

Participant milestones

Participant milestones
Measure	Arm 1 Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles. Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=1 Participants Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles. Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants
Sex: Female, Male Female	0 Participants n=39 Participants
Sex: Female, Male Male	1 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	1 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	1 participants n=39 Participants

PRIMARY outcome

Timeframe: up to 63 days

Outcome measures

Outcome measures
Measure	Arm 1 n=1 Participants Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles. Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.
Surgically Resectable	1 Participants

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1 n=1 participants at risk Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles. Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.
Skin and subcutaneous tissue disorders rash	100.0% 1/1 • Number of events 1 • neoadjuvant treatment period - up to 63 days
Gastrointestinal disorders mucositis	100.0% 1/1 • Number of events 1 • neoadjuvant treatment period - up to 63 days
Investigations hypomagnesemia	100.0% 1/1 • Number of events 1 • neoadjuvant treatment period - up to 63 days
Respiratory, thoracic and mediastinal disorders cough	100.0% 1/1 • Number of events 1 • neoadjuvant treatment period - up to 63 days
Blood and lymphatic system disorders neutropenia	100.0% 1/1 • Number of events 1 • neoadjuvant treatment period - up to 63 days

Additional Information

Balazs Halmos

Montefiore Medical Center

Phone: 7184058404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place