FastAct II

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RS Sardjito, Jogjakarta; RS Persahabatan, Jakarta; RS Soetomo, Surabaya.
No Registry
INA-XL122KL
Tanggal Input Registry : 29-09-2017

13-10-2009
Median Progression Free Survival (PFS) Time [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]
Percentage of Participants Alive and Free From Disease Progression [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]; Median PFS Time Based on Different Subgroups [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]; Median Overall Survival (OS) Time-Overall and Among Different Subgroups [ Time Frame: Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years]) ]; Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups [ Time Frame: Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years]) ]; Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]; Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]; Duration of Response [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ] Time to Progression [ Time Frame: Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years]) ]; Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS) [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]; Time to Symptomatic Progression [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]; Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0 [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]; Time to Deterioration in TOI Using FACT-L Version 4.0 [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]; Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0 [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]; Time to Deterioration in QOL Using FACT-L Version 4.0 [ Time Frame: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years) ]; Median Follow-up Time During the Study [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years]) ].
 
FastAct II
A randomised, placebo-controlled, double-blind phase III study of intercalated Tarceva (erlotinib) or placebo with gemcitabine/platinum as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer (NSCLC)
Observasional
In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m(2) on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m(2) on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population.
451
 

Inclusion Criteria:

adult patients, >=18 years of age; advanced (stage IIIB/IV)non-small cell lung cancer; measurable disease; Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Exclusion Criteria:

prior exposure to agents directed at the HER axis; prior chemotherapy or systemic anti-tumor therapy after advanced disease; unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; brain metastasis or spinal cord compression.
 
Komite Etik Universitas Gadjah Mada, KE/FK/530/EC 05 November 2009, 23Apr2014; Komite Etik Fakultas Kedokteran Universitas Indonesia, 430/H2.F1/ETIK/VI/2014, 16Jun2014; Komite Etik RS Soetomo, 340/113/Komitlitkes/VII/2014, 10 Juli 2014.
NA
PN.01.06.313.3.08.1.4.6173, 22Agt2014.
MO22201
Dr. Djohan Kurnianda, SpPD-KHOM; Dr. Elisna Syahruddin, SpP(K), PhD; Prof.Dr. Benjamin Palgunadi Margono, SpP(K).