NEJ062

JRCT ID: jRCTs061240019

Registered date:06/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 06/06/2024
• Target sample size: 33
• Study type: Interventional

Intervention(s)

All patients will receive platinum-doublet + durvalumab + tremelimumab as protocol treatment. Protocol treatment is continued until discontinuation criteria are met, such as disease progression or unacceptable AEs.
The treatment regimen is selected by the investigators from the following regimens.

1.In the case of non-squamous NSCLC, choose one of the following:
1)Induction therapy: cisplatin 75 mg/m2 (day1) + pemetrexed 500 mg/m2 (day1) + durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 3 weeks, for up to 4 cycles
Maintenance therapy: pemetrexed 500 mg/m2 (day1) + durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 4 weeks
Tremelimumab as maintenance therapy is administered for the second cycle only.
2)Induction therapy: carboplatin AUC 5 (day1) + pemetrexed 500 mg/m2 (day1) + durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 3 weeks, for up to 4 cycles
Maintenance therapy: pemetrexed 500 mg/m2 (day1) + durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1),every 4 weeks
Tremelimumab as maintenance therapy is administered for the second cycle only.
3)Induction therapy: carboplatin AUC 6 (day1) + nab-paclitaxel 100 mg/m2 (day1, 8, 15) + durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 3 weeks, up to 4 cycles
Maintenance therapy: durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 4 weeks
Tremelimumab as maintenance therapy is administered for the second cycle only.

2.In the case of squamous NSCLC, the regimen is as follows:
Induction therapy: carboplatin AUC 6 (day1) + nab-paclitaxel 100 mg/m2 (day1, 8, 15) + durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 3 weeks, up to 4 cycles
Maintenance therapy: durvalumab 1500 mg (day1) + tremelimumab 75 mg (day1), every 4 weeks
Tremelimumab as maintenance therapy is administered for the second cycle only.

Outcome(s)

• Primary Outcome: Objective response rate (ORR)
• Secondary Outcome: Progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), 1-year PFS rate, 1-year OS rate, safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
2.Negative or unknown activating driver oncogene mutation/ translocation.
3.Patients must have received definitive concurrent chemoradiotherapy and durvalumab as consolidation therapy for NSCLC (locally advanced, unresectable, stage III or post operative, locally reccurent disease).
4.Durvalumab has not been permanently discontinued due to adverse events (AEs), or durvalumab has been held due to AEs and subsequently reinitiated.
5.Disease progression was observed at least 4 months after the date of completion of thoracic radiotherapy, and disease progression was observed during durvalumab therapy or within 6 months of the last dose of durvalumab.
6.Age is at least 18 years.
7.ECOG Performance status of 0 or 1.
8.Meet the following criteria for major organ function within 14 days prior to enrolment.
a.Neutrophil count: >= 1,500 /mm3
b.Hemoglobin: >= 9.0 g/dL
c.Platelet count: >= 10.0 x 104 /mm3
d.AST, ALT: <= 2.5 times the upper limit of the facility reference value
e.Total bilirubin: <= 1.5 times the upper limit of the facility reference value
f.Serum creatinine: < 1.5 mg/dL
g.SpO2 >= 95 %(room air)

Exclude criteria

1.Active interstitial lung disease, or radiation pneumonitis/ organizing pneumonia due to radiation therapy requiring corticosteroids.
2.Previous immunotherapy has caused >=Grade 3 immune-related adverse events (irAEs) defined by CTCAE v5.0 (excluding endocrine disorders), or irAEs have not improved to the baseline condition prior to initiation of immunotherapy (excluding endocrine disorders).
3.Clinically unstable or symptomatic brain metastasis, meningeal carcinomatosis or spinal cord compression.
4.Active Hepatitis B or C, HIV infection, or active tuberculosis infection.
5.Active autoimmune disease, history of immunodeficiency or serious complications.
6.Another primary malignancy within 5 years.
7.Patients who are judged inappropriate to participate in the study by the principal investigator or sub-investigators.

Related Information

• Primary Sponsor: TSUBATA Yukari
• Secondary Sponsor: Nonprofit Organization, North East Japan Study Group