Trial Outcomes & Findings for Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®. (NCT NCT01652469)

Last Updated: 2022-08-24

Results Overview

Time from the date of randomization until documented progression or death without documented progression. Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) Target lesions:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.(Note: the appearance of one or more new lesions is also considered progression). Non-target lesions:Unequivocal progression of existing non-target lesions. (Note:the appearance of one or more new lesions is also considered progression). To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that,even in presence of SD or PR in target disease, the overall tumour burden has increased sufficiently

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

81 participants

Primary outcome timeframe

The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months.

Results posted on

2022-08-24

Participant Flow

Discrepancy between nb of enrolled pts and nb of pts who started treatment,because 1 patient,who shouldn't have been included (exclusion criteria),was enrolled in the database by mistake.In the database patient's status couldn't be changed from "Enrolled" to "Ineligible",thus this patient considered enrolled,but was not included in efficacy cohort.

Participant milestones

Participant milestones
Measure	A: Erlotinib Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Overall Study STARTED	38	42
Overall Study COMPLETED	37	36
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Reasons for withdrawal
Measure	A: Erlotinib Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A: Erlotinib n=38 Participants Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=42 Participants Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.	Total n=80 Participants Total of all reporting groups
Age, Continuous	66.7 years n=5 Participants	70.1 years n=7 Participants	68.7 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	35 Participants n=7 Participants	66 Participants n=5 Participants
Smoking history Current	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Smoking history Former (>100 cigarettes & >12 months smoke-free)	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Smoking history Never	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
ECOG performance status 0	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
ECOG performance status 1	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
ECOG performance status 2	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
VeriStrat status Good	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
VeriStrat status Poor	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months.

Outcome measures

Outcome measures
Measure	A: Erlotinib n=38 Participants Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=42 Participants Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Progression-free Survival	1.6 months Interval 1.3 to 3.8	3.0 months Interval 1.9 to 4.2

SECONDARY outcome

Timeframe: All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized

Defined as time from the date of randomization until death from any cause.

Outcome measures

Outcome measures
Measure	A: Erlotinib n=38 Participants Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=42 Participants Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Overall Survival	7.1 months Interval 4.4 to 10.6	7.1 months Interval 5.3 to 8.6

SECONDARY outcome

Timeframe: Same as primary outcome: 24 months

Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment.

Outcome measures

Outcome measures
Measure	A: Erlotinib n=38 Participants Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=42 Participants Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Objective Response Partial response	4 Participants	6 Participants
Objective Response Stable Disease	15 Participants	18 Participants
Objective Response Progressive Disease	17 Participants	14 Participants
Objective Response Non-Evaluable	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Same as primary outcome: 24 months

Disease control is defined as achieving objective response or stable disease for at least 6 weeks.

Outcome measures

Outcome measures
Measure	A: Erlotinib n=38 Participants Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=42 Participants Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Disease Control Disease Control	19 Participants	24 Participants
Disease Control No Disease Control	19 Participants	18 Participants

SECONDARY outcome

Timeframe: Same as primary outcome: 24 months

Population: One patient from the Docetaxel arm never started treatment.

Adverse events classified according to NCI CTCAE version 4

Outcome measures

Outcome measures
Measure	A: Erlotinib n=38 Participants Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=41 Participants Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Number of Participants With Adverse Events Experienced SAE	7 Participants	19 Participants
Number of Participants With Adverse Events Experienced AE/SAE	36 Participants	39 Participants
Number of Participants With Adverse Events No AE/SAE	2 Participants	2 Participants

Adverse Events

A: Erlotinib

Serious events: 7 serious events

Other events: 36 other events

Deaths: 7 deaths

B: Docetaxel

Serious events: 19 serious events

Other events: 39 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Heidi Roschitzki-Voser, Lead Trial Activities

European Thoracic Oncology Platform (ETOP)

Phone: +41 31 511 94 18

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	A: Erlotinib n=38 participants at risk Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=41 participants at risk Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	14.6% 6/41 One patient from the Docetaxel arm never started treatment.
Infections and infestations Lung infection	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	4.9% 2/41 One patient from the Docetaxel arm never started treatment.
Infections and infestations Bronchial infection	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	4.9% 2/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Cardiac disorders Atrial flutter	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.
Cardiac disorders Cardiac arrest	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
General disorders Death NOS	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
General disorders Fatigue	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
General disorders Fever	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Injury, poisoning and procedural complications Hip fracture	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.
Infections and infestations Infections and infestations	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Jejunal perforation	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Investigations Neutrophil count decreased	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.
Renal and urinary disorders Renal and urinary disorders	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Infections and infestations Sepsis	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Infections and infestations Urinary tract infection	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Vomiting	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.

Measure	A: Erlotinib n=38 participants at risk Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.	B: Docetaxel n=41 participants at risk Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.
General disorders Fatigue	28.9% 11/38 One patient from the Docetaxel arm never started treatment.	58.5% 24/41 One patient from the Docetaxel arm never started treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	42.1% 16/38 One patient from the Docetaxel arm never started treatment.	31.7% 13/41 One patient from the Docetaxel arm never started treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	71.1% 27/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Respiratory, thoracic and mediastinal disorders Cough	26.3% 10/38 One patient from the Docetaxel arm never started treatment.	34.1% 14/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Diarrhea	26.3% 10/38 One patient from the Docetaxel arm never started treatment.	26.8% 11/41 One patient from the Docetaxel arm never started treatment.
Metabolism and nutrition disorders Anorexia	18.4% 7/38 One patient from the Docetaxel arm never started treatment.	19.5% 8/41 One patient from the Docetaxel arm never started treatment.
Investigations Neutrophil count decreased	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	29.3% 12/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Mucositis oral	13.2% 5/38 One patient from the Docetaxel arm never started treatment.	22.0% 9/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Nausea	10.5% 4/38 One patient from the Docetaxel arm never started treatment.	24.4% 10/41 One patient from the Docetaxel arm never started treatment.
Skin and subcutaneous tissue disorders Alopecia	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	26.8% 11/41 One patient from the Docetaxel arm never started treatment.
General disorders Pain	10.5% 4/38 One patient from the Docetaxel arm never started treatment.	17.1% 7/41 One patient from the Docetaxel arm never started treatment.
Skin and subcutaneous tissue disorders Dry skin	21.1% 8/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Infections and infestations Lung infection	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	4.9% 2/41 One patient from the Docetaxel arm never started treatment.
Nervous system disorders Dizziness	7.9% 3/38 One patient from the Docetaxel arm never started treatment.	9.8% 4/41 One patient from the Docetaxel arm never started treatment.
General disorders Fever	10.5% 4/38 One patient from the Docetaxel arm never started treatment.	7.3% 3/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Vomiting	7.9% 3/38 One patient from the Docetaxel arm never started treatment.	7.3% 3/41 One patient from the Docetaxel arm never started treatment.
General disorders Edema limbs	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	9.8% 4/41 One patient from the Docetaxel arm never started treatment.
General disorders Flu-like symptoms	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	7.3% 3/41 One patient from the Docetaxel arm never started treatment.
Vascular disorders Hypertension	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	9.8% 4/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Abdominal pain	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Blood and lymphatic system disorders Anemia	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	4.9% 2/41 One patient from the Docetaxel arm never started treatment.
Investigations Aspartate aminotransferase increase	7.9% 3/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Eye disorders Conjuctivitis	7.9% 3/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Constipation	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	7.3% 3/41 One patient from the Docetaxel arm never started treatment.
General disorders Death NOS	7.9% 3/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	9.8% 4/41 One patient from the Docetaxel arm never started treatment.
Musculoskeletal and connective tissue disorders Bone pain	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Investigations Creatinine increase	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Dysphagia	2.6% 1/38 One patient from the Docetaxel arm never started treatment.	4.9% 2/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Gastrointestinal disorders	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Skin and subcutaneous tissue disorders Nail discoloration	0.00% 0/38 One patient from the Docetaxel arm never started treatment.	7.3% 3/41 One patient from the Docetaxel arm never started treatment.
Gastrointestinal disorders Oral dysesthesia	5.3% 2/38 One patient from the Docetaxel arm never started treatment.	2.4% 1/41 One patient from the Docetaxel arm never started treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	7.9% 3/38 One patient from the Docetaxel arm never started treatment.	0.00% 0/41 One patient from the Docetaxel arm never started treatment.