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

NCT ID: NCT01774721

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-09
• Study Completion Date: 2022-01-27

Brief Summary

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.

Detailed Description

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

Conditions

Non-small Cell Lung Cancer With EGFR-Activating Mutations

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gefitinib

Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.

Group Type: ACTIVE_COMPARATOR

Gefitinib

Intervention Type: DRUG

Gefitinib 250 mg tablets, continuous oral daily dosing.

Dacomitinib (PF-00299804)

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing.

Group Type: EXPERIMENTAL

Dacomitinib (PF-00299804)

Intervention Type: DRUG

Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.

Interventions

Dacomitinib (PF-00299804)

Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.

Intervention Type: DRUG

Gefitinib

Gefitinib 250 mg tablets, continuous oral daily dosing.

Intervention Type: DRUG

Other Intervention Names

Dacomitinib; Iressa

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Beijing, , China

Changchun, , China

Changsha, , China

Chengdu, , China

Chongqing, , China

Fuzhou, , China

Guangzhou, , China

Hangzhou, , China

Hefei, , China

Nanning, , China

Shanghai, , China

Shenyang, , China

Tianjin, , China

Wuhan, , China

Wuxi, , China

Hong Kong, , Hong Kong

Shatin, , Hong Kong

Catania, , Italy

Lecco, , Italy

Livorno, , Italy

Meldola, , Italy

Milan, , Italy

Napoli, , Italy

Perugia, , Italy

Ravenna, , Italy

Roma, , Italy

Trento, , Italy

Viterbo, , Italy

Hokkaido, Asahikawa, Japan

Kashiwa, Chiba, Japan

Matsuyama, Ehime, Japan

Yokohama, Kanagawa, Japan

Tokyo, Koto-ku, Japan

Sakai, Osaka, Japan

Sayama, Osaka, Japan

Sunto-gun, Shizouka, Japan

Chuo-Ku, Tokyo, Japan

Gdansk, , Poland

Olsztyn, , Poland

Poznan, , Poland

Warsaw, , Poland

Seoul, , South Korea

Ávila, , Spain

Barcelona, , Spain

Bilbao, , Spain

Cáceres, , Spain

Córdoba, , Spain

Donostia / San Sebastian, , Spain

Las Palmas, , Spain

Madrid, , Spain

Málaga, , Spain

Seville, , Spain

Countries

China; Hong Kong; Italy; Japan; Poland; South Korea; Spain

References

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Reference Type: DERIVED

PMID: 39360943 (View on PubMed)

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Lee M, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Wu YL. Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. J Clin Oncol. 2018 Aug 1;36(22):2244-2250. doi: 10.1200/JCO.2018.78.7994. Epub 2018 Jun 4.

Reference Type: DERIVED

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Reference Type: DERIVED

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Other Identifiers

DP312804

Identifier Type: OTHER

Identifier Source: secondary_id

A7471050

Identifier Type: -

Identifier Source: org_study_id