Trial Outcomes & Findings for Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer (NCT NCT00103207)

Last Updated: 2023-06-28

Results Overview

Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Results posted on

2023-06-28

Participant Flow

The study opened to accrual on August 10, 2005, accrued its first patient on October 13, 2005, and closed to accrual on December 12, 2008 with final accrual of 72 patients.

Participant milestones

Participant milestones
Measure	Cetuximab Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.
Overall Study STARTED	72
Overall Study Eligible Patients w/ Confirmed Diagnosis	41
Overall Study Eligible Patients w/ Smoking Status Data	37
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.
Overall Study Adverse Event	3
Overall Study Death	1
Overall Study Withdrawal by Subject	2
Overall Study Other complicating disease	1
Overall Study Ineligible	4
Overall Study Diagnosis of BAC not confirmed	27

Baseline Characteristics

Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab n=41 Participants Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Population: Only eligible and treated patients with confirmed diagnosis are included in this analysis.

Outcome measures

Outcome measures
Measure	Cetuximab n=41 Participants Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.	Former/Current Smoker Eligible and treated patients who are former or current smokers.
Objective Response Rate (Proportion of Patients With Objective Response)	0.07 Proportion Interval 0.02 to 0.18	—

SECONDARY outcome

Timeframe: Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Population: Only eligible and treated patients with confirmed diagnosis are included.

Overall survival is defined as the time from registration to death.

Outcome measures

Outcome measures
Measure	Cetuximab n=41 Participants Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.	Former/Current Smoker Eligible and treated patients who are former or current smokers.
Overall Survival	17.9 Months Interval 10.6 to 31.5	—

SECONDARY outcome

Timeframe: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Population: Only eligible and treated patients with confirmed diagnosis are included in the analysis.

Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

Outcome measures

Outcome measures
Measure	Cetuximab n=41 Participants Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.	Former/Current Smoker Eligible and treated patients who are former or current smokers.
Time to Progression	3.8 Months Interval 2.6 to 5.7	—

SECONDARY outcome

Timeframe: Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline

Population: Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.

Medians of overall survival by smoking status are reported.

Outcome measures

Outcome measures
Measure	Cetuximab n=7 Participants Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.	Former/Current Smoker n=30 Participants Eligible and treated patients who are former or current smokers.
Overall Survival by Smoking Status	40.9 Months Interval 7.2 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	15.5 Months Interval 8.9 to 30.2

SECONDARY outcome

Timeframe: Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline

Population: Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.

Medians of time to progression by smoking status are reported.

Outcome measures

Outcome measures
Measure	Cetuximab n=7 Participants Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced. Only eligible patients with confirmed diagnosis are included in the main analysis.	Former/Current Smoker n=30 Participants Eligible and treated patients who are former or current smokers.
Time to Progression by Smoking Status	2.6 Months Interval 1.8 to 6.0	3.7 Months Interval 2.6 to 5.7

Adverse Events

Cetuximab

Serious events: 27 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab n=72 participants at risk All treated patients were evaluated for toxicities.
Immune system disorders Allergic reaction	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Lymphopenia	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	9.7% 7/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Dry skin	2.8% 2/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Nail changes	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Pruritus/itching	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	15.3% 11/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Hand-foot reaction	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Dehydration	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection Gr0-2 neut, skin	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection Gr0-2 neut, ungual	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection Gr0-2 neut, urinary tract	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Creatinine, increased	2.8% 2/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypophosphatemia	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperkalemia	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Neuropathy-sensory	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Back, pain	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Head/headache	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Skin, pain	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Vascular disorders Thrombosis/thrombus/embolism	1.4% 1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.

Other adverse events

Other adverse events
Measure	Cetuximab n=72 participants at risk All treated patients were evaluated for toxicities.
Immune system disorders Allergic reaction	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Blood and lymphatic system disorders Anemia	37.5% 27/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Leukocytes, decreased	11.1% 8/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Neutrophils, decreased	9.7% 7/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Platelets, decreased	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	61.1% 44/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fever w/o neutropenia	11.1% 8/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
General disorders Rigors/chills	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Weight loss	16.7% 12/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Dry skin	26.4% 19/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Nail changes	13.9% 10/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Pruritus/itching	19.4% 14/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	30.6% 22/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	83.3% 60/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Hand-foot reaction	12.5% 9/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Skin-other	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	20.8% 15/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Constipation	22.2% 16/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	30.6% 22/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dyspepsia	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	8.3% 6/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	15.3% 11/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	31.9% 23/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Taste disturbance	12.5% 9/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	11.1% 8/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
General disorders Edema limb	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Alkaline phosphatase increased	11.1% 8/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Alanine aminotransferase increased	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Aspartate aminotransferase increased	8.3% 6/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypocalcemia	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Investigations Creatinine, increased	12.5% 9/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	44.4% 32/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoglycemia	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypomagnesemia	27.8% 20/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypophosphatemia	6.9% 5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypokalemia	8.3% 6/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Dizziness	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Neuropathy-sensory	8.3% 6/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Eye disorders Dry eye syndrome	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Head/headache	15.3% 11/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Muscle, pain	5.6% 4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 6/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 6/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place