ACHILLES study/TORG1834

Phase 3

Active, not recruiting

• Conditions: Advanced non-small cell lung cancer

• Registration Number: JPRN-jRCTs031180175
• Lead Sponsor: TANAKA Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Objective response rate, Overall survival, Time to treatment failure, Safety