TORG2442/CASTLE study

Recruiting

• Conditions: Advanced/ recurrent Non-small cell lung cancer with Interstitial lung disease

• Registration Number: jRCTs031240743

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-25
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

First registration

1. Histologically or cytologically proven non-small cell lung cancer (NSCLC).
2. Unresectable stage 3/4 or recurrent.
3. Chronic fibrotic Interstitial lung disease. HRCT revealed (1) reticular shadow with basal and peripheral predominance suggestive of UIP pattern, or (2) peribronchovascular shadow suggestive of NSIP pattern.
4. CBDCA+nab-PTX is scheduled or administered as first line chemotherapy.
5. Before second line chemotherapy. (Dose not include ICI.)
6. Age>=18 years.
7. Written informed consent.

Second registration

1. Completed 4-6 cycles of first line chemotherapy. (CBDCA+nab-PTX)
2. Best Overall Response of first line chemotherapy was CR, PR or SD. (Confirmation is not required.)
3. Developed signs of disease progression with a time interval >= 90 days between relapse and the last administration of CBDCA as first line chemotherapy.
4. With measurable or evaluable lesions according to RECIST Version1.1.
5. ECOG Performance Status =<1.
6. Laboratory tests performed within 14 days prior to registration meet the following criteria. (The same day of the week two weeks prior is acceptable based on the registration date. Delay due to national holidays is acceptable.)

• Neutrophil count: >=1,500 / mm3
• Platelet count: >=100,000 / mm3
• AST: =<100 IU/L (=<200 IU/L if liver metastases present)
• ALT: =<100 IU/L (=<200 IU/L for liver metastasis)
• Total bilirubin: =<1.5 mg/dL (=<3.0 mg/dL for indirect hyperbilirubinemia)
• Serum creatinine: =<1.5 mg/dL
• SpO2: >=90%
• %FVC: >=50%, %DLco: >=36% (performed within 90 days prior to registration is acceptable)

7. Expected survival of at least 12 weeks.
8. Written informed consent.

Exclusion Criteria

First registration

1. Developed signs of disease progression with a time interval < 90 days between relapse and the last administration of CBDCA as 1st line chemotherapy.
2. Other interstitial lung disease of known etiology.
3. History of acute exacerbation of Interstitial lung disease.
4. Treatment history with thoracic radiotherapy.
5. Other conditions not suitable for this study.
6. Difficult to informed consent.

Second registration

1. Developed signs of disease progression with a time interval < 90 days between relapse and the last administration of CBDCA as 1st line chemotherapy.
2. Administered ICI before disease progression after 1st line chemotherapy.
3. With treatment period with nab-PTX monotherapy. (This refers to cases that nab-PTX monotherapy without CBDCA has been administered three or more times sequentially.)
4. Prior chemotherapy without CBDCA+nab-PTX. (Does not include ICI and neoadjuvant/adjuvant chemotherapy as perioperative chemotherapy.)
5. Grade 3 or higher peripheral sensory/motor neuropathy.
6. History of acute exacerbation of Interstitial lung disease.

• Imaging changes in Interstitial lung disease compared to the start of first-line therapy are considered chronic progression, not acute exacerbation, and are eligible if other criteria are met.

7. Treatment with steroids at a daily dose>10mg of prednisolone equivalent up to 14 days before registration.
8. Treatment history with thoracic radiotherapy.
9. Symptomatic brain metastasis or spinal cord metastases.

• If brain metastases are present, the patient is eligible if asymptomatic or if more than 15 days have passed since local treatment and corticosteroids are less than 10 mg/day of prednisolone equivalent.

10. Uncontrollable Pleural/pericardial effusions, or ascites.

• Patients with pleural/pericardial effusions, or ascites that do not require continuous drainage or are clinically stable after drainage are eligible. (The period must have passed for 7 days after the drainage has ended.

11. Active multiple primary neoplasms diagnosed within 3 years.

• Duplication of carcinoma in situ (intraepithelial carcinoma) that is cured by local treatment is not included in active multiple primary neoplasms.

12. Active hepatitis B, hepatitis C, or HIV infection.

• If the patient is positive for HBs antigen or HBV-DNA, he/she is excluded.
• If the patient is positive for HBs antibody or HBc antibody, HBV DNA level is measured and the virus level is negative, the patient is eligible.
• If the patient is positive for HCV antibody, he/she is excluded.

13. Serious complications such as thromboembolism, peptic ulcer, cerebral ischemic attack, congestive heart failure, unstable angina pectoris, uncontrolled arrhythmia or myocardial infarction within 6 months.
14. Hypersensitivity to any of the ingredients or additives of CBDCA or nab-PTX.
15. Pregnant women, lactating women, and women with a positive pregnancy test. Men and women who are pregnant, lactating women, and women who have had a positive pregnancy test or who do not intend to use contraception.
16. Active infection.
17. Other conditions not suitable for this study.

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
3m PFS without AE-ILD rate	3 months	Progression-free survival without acute exacerbation of interstitial lung disease rate