ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Pfizer

Status and phase

Completed

Phase 3

Conditions

Non-small Cell Lung Cancer With EGFR-Activating Mutations

Treatments

Drug: Dacomitinib (PF-00299804)

Drug: Gefitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01774721

A7471050

DP312804 (Other Identifier)

Details and patient eligibility

About

This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

Full description

452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

Enrollment

452 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21).
It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study
No prior treatment with systemic therapy for locally advanced or metastatic NSCLC. Minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant systemic therapy and recurrence of NSCLC
Adequate tissue sample must be available for central analyses.
Adequate renal, hematologic, liver function.
ECOG PS of 0-1.
Radiologically measurable disease.

Exclusion criteria

Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
Any history of brain metastases or leptomeningeal metastases.
Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC.
Any surgery(not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments
Any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug.
Current enrollment in another therapeutic clinical study.
History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease
Uncontrolled medical disorders.
Prior malignancy and concurrent malignancy except for non melanoma skin cancer or in-situ cervical cancer with no evidence of active disease.
Use of narrow therapeutic index drugs that are CYP2D6 substrates from screening to randomization.