LUX-Head & Neck 2;A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma

LUX-Head & Neck 2;A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma - LUX-Head & Neck 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39253

Enrollment

Registered

2011-07-05

Start date

2012-09-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer squamous cell carcinoma of the head and neck

Interventions

During the treatment period, patients will visit the investigational site in weeks one, two, and four, and then every four weeks for assessment of safety parameters and AEs as outlined in the Flow C

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Histologically or cytologically confirmed loco-regionally advanced squamous cell carcinoma, stage III, IVa, or IVb, of the oral cavity, oropharynx, or hypopharynx, or larynx stage IVa or IVb ;*Unresected tumour prior to chemo-radiotherapy due to:;o Technical unresectability (e.g. tumour fixation/invasion to either base of the skull, cervical vertebrae, nasopharynx, or fixed lymph nodes); and/or; o Low surgical curability (T3-T4, N2-N3 excluding T1N2); and/or; o Organ preservation; *Concomitant platinum-based chemo-radiotherapy (for minimum requirements see the protocol) completed no longer than 24 weeks prior to randomisation. At randomisation, chemo-radiotherapy induced side effects CTCAE grade * 2; *No evidence of disease (NED), defined as no measurable or palpable tumour on clinical and radiographic (e.g. CT scan or MRI) examinations as judged by the investigator in either of the following: a) No residual tumour after CRT; b) No residual tumour after CRT followed by R0 tumour resection; c) No evidence of nodal disease after CRT followed by neck dissection; In case of palpable mass, NED must be confirmed by biopsy; *ECOG performance status 0 or 1 at the time of randomisation

Exclusion criteria

Exclusion criteria: -Exclusion 1 is deleted with amendment 2 (protocol revision 03) -Patients with smoking history of * 10 pack years and with primary tumour site base of tongue -Patients with smoking history of * 10 pack years and with primary tumour site tonsil -Primary cancer of nasopharynx, sinuses, or salivary glands -Prior treatment with EGFR-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for treatment of HNSCC

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this trial is Disease Free Survival (DFS), defined as the time from randomisation until recurrence of tumour or death of any cause, whichever occurs first.	—

Secondary

Measure	Time frame
The secondary endpoints DFS rate at 2 years Overall survival (OS), defined as the time from randomisation until death (irrespective of reason) Health related quality of life (HRQOL)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)