ACHILLES study/TORG1834

JRCT ID: jRCTs031180175

Registered date:04/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced non-small cell lung cancer
• Date of first enrollment: 25/04/2019
• Target sample size: 106
• Study type: Interventional

Intervention(s)

Experimental arm:Afatinib
Afatinib 40mg or 30mg daily until disease progression
(Investigators can choice a 30mg or 40mg dose of afatinib according to patients condition)
Standard arm: Cisplatin(CDDP) or Carboplatin(CBDCA) plus Pemetrexed(Pem)
Induction therapy
1.CDDP 75mg/m2 day1 + Pem 500mg/m2 day1 q3w
2.CBDCA AUC6 + Pem 500mg/m2 day1 q3w
3.CBDCA AUC5 + Pem 500mg/m2 day1 q3w (elderly)
Until 4 cycle
(Investigators can choice 1. 2. or 3. according to patients condition)
Maintenance therapy
After 4cycle of therapy, patients with complete response, partial response or stable disease receive maintenance therapy with pemetrexed.
Pem 500mg/m2 day1 q3w until progression
All of patients receive oral folic acid daily and a vitamin B12 injection every 9weeks

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Objective response rate, Overall survival, Time to treatment failure, Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically and/or cytologically documented non-squamous, non-small cell lung cancer patients with stage IIIB, IIIC or IV, and who are ineligible for curative radiotherapy, or relapsed after postoperative chemotherapy or chemoradiotherapy for locally advanced disease.
2) Sensitizing EGFR Uncommon mutation patient ((1).or(2) with(3))
(1) Patient with EGFR uncommon mutations
(2) Patient with compound mutations
(3) Patient without resistant EGFR uncommon mutation (T790M, Exon 20 insertions)
3) No prior therapy with chemotherapy, molecular targeted therapy and immune-check point inhibitors
4) 20 years or older
5) ECOG PS 0 or 1
6) Adequate organ function
7) Patients with at least one evaluable lesion
(regardless of whether lesions can be measured using RECIST version 1.1)
8) Life expectancy more than three months
9) Written informed consent for translational research
Written informed consent

Exclude criteria

1)Patients who are difficult to treat enrolled doses due to toxicity of afatinib
2)History of drug-induced pneumonitis/Interstitial pneumonia detectable with chest CT scan.
3)Symptomatic brain metastasis/ leptomeningitis
4)Bone metastasis to treat by operation or radiation therapy
5)Uncontrollable pleural, peritoneal or pericardial effusion
6)Prior thoracic palliative radiotherapy within 2wks
7)SCLC transformation
8)History of active double cancer
9)Severe infection
10)Active HBV infection
11)No intention to birth control
12)Unstable psychic disorder
13)Under treatment of steroid therapy or immunosuppressive therapy
14)History of allergic reaction
Decision of ineligibility by a physician

Related Information

• Primary Sponsor: TANAKA Hiroshi
• Secondary Sponsor: MIURA Satoru,Thoracic Oncology Research Group