Trial Outcomes & Findings for Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer (NCT NCT00387127)

Last Updated: 2015-06-25

Results Overview

Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months

Results posted on

2015-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Chemoradiotherapy + Placebo, Followed by Placebo Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Overall Study STARTED	33	34
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	33	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemoradiotherapy + Placebo, Followed by Placebo Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Overall Study Lost to Follow-up	0	4
Overall Study Death	16	16
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	3	2
Overall Study Required by Protocol Amendment #4	12	10
Overall Study Serious Adverse Event	1	1
Overall Study Sponsor Unblinded	1	0

Baseline Characteristics

Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.	Total n=67 Participants Total of all reporting groups
Age, Continuous	56.5 Years STANDARD_DEVIATION 6.61 • n=5 Participants	55.8 Years STANDARD_DEVIATION 5.73 • n=7 Participants	56.1 Years STANDARD_DEVIATION 6.15 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months

Population: Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review	12 Participants	18 Participants

SECONDARY outcome

Timeframe: From the date of randomization until 6 months post chemoradiation treatment, assessed after a median time of 13 months of follow-up

Population: ITT Population

Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the CRT, as determined by the investigator. Tumor response was assessed using modified RECIST criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants With CR, as Assessed by the Investigator	7 Participants	17 Participants

SECONDARY outcome

Timeframe: From the date of randomization until the date of disease progression or death due to any cause, assessed after a median of 22 months of follow-up

Population: ITT Population

PFS=the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Per RECIST, progressive disease=a \>=20% increase in the sum of the longest diameter of target lesions (TLs), or the appearance of \>=1 new L, symptomatic progression and/or unequivocal progression of existing non-TLs. For participants who did not progress or die at the time of reporting (data cut-off 1-Aug-2014), PFS data were censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Progression-Free Survival (PFS), as Assessed by the Investigator	12.1 Months Interval 7.3 to There were too few events to allow for the calculation of the upper limit of the confidence interval.	20.4 Months Interval 10.8 to There were too few events to allow for the calculation of the upper limit of the confidence interval.

SECONDARY outcome

Timeframe: From the date of randomization until the date of death due to any cause, assessed after a median of 30.9 months

Population: ITT Population

OS is defined as the time from randomization until death due to any cause. Time to death (data cut-off 1-Aug-2014) was censored at the time of last contact for participants who did not die.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Overall Survival (OS)	23.0 Months Interval 14.2 to There were too few events to allow for the calculation of the upper limit of the confidence interval.	48.4 Months Interval 18.8 to There were too few events to allow for the calculation of the upper limit of the confidence interval.

SECONDARY outcome

Timeframe: From the date of randomization until the date of death due to disease under study, assessed after a median of 30.9 months

Population: ITT Population

The number of participants who died due to progressive disease (a \>=20% increase in the sum of the longest diameter of target lesions, or the appearance of \>=1 new lesion, symptomatic progression and/or unequivocal progression of existing non-target lesions), or died due to head and neck cancer without evidence of disease progression, after randomization in the study is presented, using a data cut of 1 August 2014.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants Who Died Due to Progressive Disease	11 Participants	8 Participants

SECONDARY outcome

Timeframe: From the date of randomization until the date of death due to disease, assessed after a median of 13 months of follow-up

Population: ITT Population. For participants who did not die, time to death was censored at the time of last contact.

Disease-specific survival is defined as the time from randomization until death due to head and neck cancer.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Disease-specific Survival	NA Months Interval 15.6 to The cumulative incidence in the placebo arm remained lower than 50%, so the median and upper quartile were not observed.	NA Months The cumulative incidence remained lower than 25% in the lapatinib arm, so neither the median nor the inter-quartile range were observed.

SECONDARY outcome

Timeframe: From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months

Population: ITT Population

Participants with loco-regional recurrence were those who had progression of disease in the T and N sites. Per the Tumor, Node, and Metastases (TNM) staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. If a participant had progression in the T or N sites, then the participant was counted as having had an event of interest.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants With Loco-regional Recurrence of Initial Disease	7 Participants	4 Participants

SECONDARY outcome

Timeframe: From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months

Population: ITT Population

Loco-regional control is defined as the time from the date of randomization until progression in the T or N site. Participants who died or had secondary primary malignancies in the head and neck region outside of the T and N site or distant metastasis were not counted as an event and were instead treated as competing risks. Per the TNM staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. Due to the minimal events reported (data cut-off 30-Sep-2010), valid analysis could not be performed for loco-regional control rate.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months

Population: ITT Population

Participants were analyzed for the occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ or part) after randomization in the study until data cut-off date 1-Aug-2014. Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants With Distant Recurrence of Initial Disease	5 Participants	8 Participants

SECONDARY outcome

Timeframe: From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months

Population: ITT Population. If a participant had a distant metastasis and then died, then the participant was counted as having had an event of interest.

Distant relapse is defined as the time from the date of randomization until the first occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ of part). Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Distant Relapse	NA Months The cumulative incidence remained below 25% in the placebo arm, so neither the median nor the inter-quartile range were observed.	NA Months Interval 56.8 to The cumulative incidence in the lapatinib arm did not reach 50% (most participants had not relapsed), so the median and the upper limit of the interquartile range were not observed.

SECONDARY outcome

Timeframe: From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months

Population: ITT Population

Participants with OR were those who achieved either a CR or partial response (PR) from the assessment of overall tumor response at 6 months (24 weeks) following completion of CRT (data cut-off 30-Sep-2010). Per RECIST, CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the long diameter (LD) of target lesions, taking as a reference, the baseline sum LD. Data are based on Week 24 scans from participants receiving study treatment at that time point.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants With Overall Response (OR), as Assessed by the Investigator	15 Participants	21 Participants

SECONDARY outcome

Timeframe: Up to 28 days prior to the date of the first dose of lapatinib/placebo start

Population: ITT Population. Only those participants who had sufficient tumor sample for testing were analyzed.

Paraffin-embedded tissue block (or sections) from archived tumor tissue sample, if available (from time of original diagnosis) or fresh tumor tissue, was sent for testing to determine intra-tumoral biomarker expression by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. Stained tumor slides or tissue micro arrays (TMAs) were scored by a pathologist from 0 (no expression) to 3+ (high expression). An expression level of \>=2+ was considered positive.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=30 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=27 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER1, Positive, n=27, 24	27 Participants	19 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER1, Negative, n=27, 24	0 Participants	5 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER2, Positive, n=26, 25	3 Participants	0 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER2, Negative, n=26, 25	23 Participants	24 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER2, Missing, n=26, 25	0 Participants	1 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER3, Positive, n=27, 22	8 Participants	5 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER3, Negative, n=27, 22	18 Participants	16 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER3, Missing, n=27, 22	1 Participants	1 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER4, Positive, n=26, 25	0 Participants	0 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER4, Negative, n=26, 25	26 Participants	24 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) HER4, Missing, n=26, 25	0 Participants	1 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) P16 Positive, n=23, 23	3 Participants	4 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) P16, Negative, n=23, 23	20 Participants	19 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) TGF-alpha, Positive, n=24, 25	7 Participants	4 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) TGF-alpha, Negative, n=24, 25	17 Participants	20 Participants
Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha) TGF-alpha, Missing, n=24, 25	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From up to 28 days prior to the first dose of lapatinib/placebo start to 8 weeks after the first dose

Population: ITT Population. Plasma proteome data have not been analyzed (tested); thus, data are not available to disclose. Based on the negative outcome of Study EGF102988 (NCT00424255), no suitable analyses have been proposed for this small sample size.

Proteomic analyses of blood plasma samples were to be conducted to identify any changes in the proteome profile that could be related to the treatment response. Examination of pre-dosing (screening) plasma protein profiles could uncover novel blood-borne protein candidate biomarkers/profiles, which could be used to predict drug response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening

Population: ITT Population. DNA/RNA from tumors has not been analyzed (tested); therefore, data are not available. No suitable analyses of DNA/RNA have been proposed for this small sample size of tumor samples.

No analysis was performed for tumor sample RNA/DNA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 days prior to the first dose of lapatinib/placebo

Population: ITT Population

Analysis was performed for HPV infection analysis from the tumor biopsy samples obtained during the Screening period. p16 was used as a marker for HPV; thus, "negative" participants did not have the p16 marker.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples Positive	3 Participants	4 Participants
Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples Negative	20 Participants	19 Participants
Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples Unknown	10 Participants	11 Participants

SECONDARY outcome

Timeframe: From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks

Population: ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.

Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a \>=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a \>=20% increase in the sum of the LD of TLs, or the appearance of \>=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of \>=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=27 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=24 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, SD	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, Unknown	4 Participants	2 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, CR	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, PR	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, PD (Week 24)	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, PD or Death (prior to Week 24)	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, Not Evaluable	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Negative, Unknown	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, CR	9 Participants	14 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, PR	4 Participants	3 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, SD	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, PD (Week 24)	4 Participants	1 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, PD or Death (prior to Week 24)	5 Participants	4 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3) Positive, Not Evaluable	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks

Population: ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Placebo, Followed by Placebo n=33 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.	Chemoradiotherapy + Lapatinib, Followed by Lapatinib n=34 Participants Participants received radiotherapy once daily (OD), with a dose/fraction \<2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, CR	5 Participants	9 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, PR	2 Participants	2 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, SD	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, PD (Week 24)	1 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, PD or Death (prior to Week 24)	2 Participants	4 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, Not Evaluable	0 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Negative, Unknown	1 Participants	1 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, CR	4 Participants	5 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, PD (Week 24)	3 Participants	1 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, PD or Death (prior to Week 24)	3 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, Not Evaluable	1 Participants	0 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, Unknown	3 Participants	1 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, PR	2 Participants	1 Participants
Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3 Positive, SD	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months

Population: ITT Population. A formal analysis of this outcome measure was never performed; thus data are not available and cannot be reported.

No analysis was not performed.

Outcome measures

Outcome data not reported

Adverse Events

Chemoradiotherapy + Placebo, Followed by Placebo

Serious events: 18 serious events

Other events: 31 other events

Deaths: 0 deaths

Chemoradiotherapy + Lapatinib, Followed by Lapatinib

Serious events: 22 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER