Trial Outcomes & Findings for AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer (NCT NCT01233687)

Last Updated: 2017-06-22

Results Overview

Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

49 participants

Primary outcome timeframe

During first cycle of treatment (3 weeks)

Results posted on

2017-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	AMG 102 + Erlotinib
Phase I RP2D AMG 102 + Erlotinib STARTED	7
Phase I RP2D AMG 102 + Erlotinib COMPLETED	7
Phase I RP2D AMG 102 + Erlotinib NOT COMPLETED	0
Phase II AMG 102 + Erlotinib STARTED	49
Phase II AMG 102 + Erlotinib Response-Evaluable	45
Phase II AMG 102 + Erlotinib COMPLETED	45
Phase II AMG 102 + Erlotinib NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	AMG 102 + Erlotinib
Phase II AMG 102 + Erlotinib Death	1
Phase II AMG 102 + Erlotinib Physician Decision	2
Phase II AMG 102 + Erlotinib Withdrawal by Subject	1

Baseline Characteristics

AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMG 102 + Erlotinib n=45 Participants
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: During first cycle of treatment (3 weeks)

Population: In the absence of DLTs among the first 7 pts treated, AMG 102 + Erlotinib (150 mg) daily (3 weeks) was declared the RP2D.

Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.

Outcome measures

Outcome measures
Measure	AMG 102 + Erlotinib n=7 Participants
Percentage of Participants That Experienced a Dose Limiting Toxicity	0 percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Six weeks from initiation of treatment with AMG 102 + Erlotinib

Population: All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)

Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.

Outcome measures

Outcome measures
Measure	AMG 102 + Erlotinib n=45 Participants
Disease Control Rate (DCR)	60 percentage of patients Interval 47.0 to 71.0

SECONDARY outcome

Timeframe: Up to 6 months

Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.

Outcome measures

Outcome measures
Measure	AMG 102 + Erlotinib n=45 Participants
Objective Response Rate (ORR/Clinical Response)	8.8 percentage of patients Interval 0.4 to 18.4

SECONDARY outcome

Timeframe: Up to 24 months (after the first patient is accrued)

Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).

Outcome measures

Outcome measures
Measure	AMG 102 + Erlotinib n=45 Participants
Progression-free Survival (PFS)	2.6 months Interval 1.4 to 3.3

SECONDARY outcome

Timeframe: Up to 24 months (after the first evaluable patient is accrued)

Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	AMG 102 + Erlotinib n=45 Participants
Overall Survival (OS)	6.6 months Interval 5.6 to 8.9

Adverse Events

AMG 102 + Erlotinib

Serious events: 18 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMG 102 + Erlotinib n=45 participants at risk Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment. Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%.
Blood and lymphatic system disorders Anemia	2.2% 1/45
Gastrointestinal disorders Diarrhea	2.2% 1/45
Gastrointestinal disorders Mucositis oral	2.2% 1/45
Gastrointestinal disorders Nausea	2.2% 1/45
Gastrointestinal disorders Vomiting	2.2% 1/45
General disorders Edema limbs	2.2% 1/45
Infections and infestations Infections and infestations - Other, specify	2.2% 1/45
Nervous system disorders Syncope	2.2% 1/45
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 5/45
Skin and subcutaneous tissue disorders Rash acneiform	2.2% 1/45
Vascular disorders Thromboembolic event	8.9% 4/45

Other adverse events

Other adverse events
Measure	AMG 102 + Erlotinib n=45 participants at risk Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment. Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%.
Blood and lymphatic system disorders Blood and lymphatic system disorders	8.9% 4/45
Blood and lymphatic system disorders Anemia	46.7% 21/45
Gastrointestinal disorders Vomiting	17.8% 8/45
Gastrointestinal disorders Nausea	35.6% 16/45
Gastrointestinal disorders Diarrhea	53.3% 24/45
General disorders Edema limbs	17.8% 8/45
General disorders Fatigue	40.0% 18/45
Investigations Platelet count decreased	11.1% 5/45
Investigations Alanine aminotransferase increased	15.6% 7/45
Investigations Creatinine increased	15.6% 7/45
Investigations Blood bilirubin increased	17.8% 8/45
Investigations Aspartate aminotransferase increased	22.2% 10/45
Investigations Lymphocyte count decreased	33.3% 15/45
Investigations Alkaline phosphatase increased	35.6% 16/45
Metabolism and nutrition disorders Anorexia	28.9% 13/45
Metabolism and nutrition disorders Hypomagnesemia	44.4% 20/45
Nervous system disorders Peripheral sensory neuropathy	6.7% 3/45
Respiratory, thoracic and mediastinal disorders Dyspnea	17.8% 8/45
Respiratory, thoracic and mediastinal disorders Cough	22.2% 10/45
Skin and subcutaneous tissue disorders Alopecia	8.9% 4/45
Skin and subcutaneous tissue disorders Rash maculo-papular	8.9% 4/45
Skin and subcutaneous tissue disorders Pruritus	11.1% 5/45
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.0% 9/45
Skin and subcutaneous tissue disorders Rash acneiform	66.7% 30/45

Additional Information

Ahmad Tarhini, MD

University of Pittsburgh

Phone: (412) 648-6578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place