Trial Outcomes & Findings for Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer) (NCT NCT00157209)

Last Updated: 2015-11-18

Results Overview

An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

171 participants

Primary outcome timeframe

From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)

Results posted on

2015-11-18

Participant Flow

First/Last participant (informed consent): 08 August 2000/02 December 2002. Clinical data cut-off: 15 March 2006. Participants randomized at 17 centers in Canada and United Kingdom.

A total of 437 participants were screened for eligibility and 171 participants were randomized.

Participant milestones

Participant milestones
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Study STARTED	88	83
Overall Study COMPLETED	78	83
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Study Ongoing at data cut-off	10	0

Baseline Characteristics

Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) n=88 Participants A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone n=83 Participants The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Total n=171 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 10.0 • n=5 Participants	58.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	59.6 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	43 Participants n=7 Participants	95 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)

Population: Analysis population included all participants randomized in the study.

Outcome measures

Outcome measures
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) n=88 Participants A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone n=83 Participants The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 Serious TEAEs	29 participants	34 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 TEAEs	88 participants	80 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 TEAEs leading to death	13 participants	20 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 TEAEs with CALGB toxicity Grade 3 or 4	42 participants	42 participants

PRIMARY outcome

Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)

Population: Analysis population included all randomized participants.

Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.

Outcome measures

Outcome measures
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) n=88 Participants A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone n=83 Participants The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Survival Time	17.2 months Interval 12.9 to 24.2	13.0 months Interval 11.2 to 16.2

SECONDARY outcome

Timeframe: At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.

Population: Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.

Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.

Outcome measures

Outcome measures
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) n=88 Participants A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone n=78 Participants The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score Baseline (n=88, 78)	109.3 Units on a scale Standard Deviation 14.8	106.4 Units on a scale Standard Deviation 15.6
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score Week 4 (n=86, 75)	109.4 Units on a scale Standard Deviation 15.9	104.1 Units on a scale Standard Deviation 17.0
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score Week 8 (n=84, 73)	108.1 Units on a scale Standard Deviation 16.1	101.6 Units on a scale Standard Deviation 17.5
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score Week 19 (n=54, 55)	108.2 Units on a scale Standard Deviation 14.9	100.1 Units on a scale Standard Deviation 20.6
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score Week 31(n=34, 36)	110.1 Units on a scale Standard Deviation 14.7	103.5 Units on a scale Standard Deviation 19.6
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score Week 43 (n=31, 20)	110.3 Units on a scale Standard Deviation 17.4	111.6 Units on a scale Standard Deviation 12.8

SECONDARY outcome

Timeframe: Time from randomization until cut-off date (15 March 2006)

Population: Analysis population included all randomized participants. "N" signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment.

T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.

Outcome measures

Outcome measures
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) n=78 Participants A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Number of Participants With Positive T-cell Proliferation	16 participants	—

SECONDARY outcome

Timeframe: Study entry, Week 8

Population: Analysis population included all randomized participants. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.

CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.

Outcome measures

Outcome measures
Measure	Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) n=88 Participants A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.	Best Supportive Care (BSC) Alone n=83 Participants The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Number of Participants With Elevated CA27-29 Antigen Levels Study entry (n=84, 82)	21 participants	21 participants
Number of Participants With Elevated CA27-29 Antigen Levels Week 8 (n=82, 71)	20 participants	18 participants

Adverse Events

Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)

Serious events: 29 serious events

Other events: 88 other events

Deaths: 0 deaths

Best Supportive Care (BSC) Alone

Serious events: 34 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee By signing this protocol, the investigator affirms to the Sponsor that information furnished by the Sponsor will be maintained in confidence, and such information will be divulged to the IRB/IEC under an appropriate understanding of confidentiality with such a committee. It is required that copies of all papers, abstracts, articles, etc. that contain study data are to be forward to the Sponsor for review 30 days prior to submission for publication.
Publication restrictions are in place

Restriction type: OTHER