Phase II Study of Cisplatin, Gemcitabine, and Necitumumab in Patients with Unresectable, Advanced or Recurrent Squamous Cell Carcinoma of the Lung after Combination of Immunotherapy and Chemotherapy.

JRCT ID: jRCTs051200138

Registered date:17/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small-cell lung cancer
• Date of first enrollment: 25/02/2021
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Patients receive combination therapy with cisplatin (75mg/m2 day1) + gemcitabine (1250mg/m2 day1 and 8) + necitumumab (800mg/body day1 and 8) up to 4 cycles if they do not meet any of the stopping conditions. If patients do not experience disease progression after completion of combination therapy, they receive necitumumab monotherapy until they meet any of the stopping conditions.

Outcome(s)

• Primary Outcome: Objective response rate: ORR

Secondary Outcome

Overall survival (OS)
Progression-free survival (PFS)
Disease control rate (DCR)
Safety profile (Adverse event rate and severity)
Efficacy analysis according to the platinum-free interval (PFI)
Efficacy analysis according to patient background (Indication for anti-angiogenic agent and type of initial treatment)
Tolerability (Administration cycle number, discontinuation, dose reduction, dose intensity)

Key inclusion & exclusion criteria

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

Include criteria

All of the following conditions must be satisfied
1. Patients have given written informed consent after the study has been fully explained prior to enrollment
2. The age at the time of obtaining consent is 20 years or older
3. Patients with histologically or cytologically confirmed squamous cell carcinoma
4. Inoperable clinical stage IIIB, IIIC, IV, or postoperative recurrence*
*Recurrence after stereotactic radiotherapy in early lung cancer (cT1-2N0M0) is eligible.
5. Patients with a measurable lesion by RECIST ver. 1.1
6. Patients without symptomatic superior vena cava (SVC) syndrome
7. Patients without symptomatic brain metastasis nor brain metastasis requiring treatment
8. Radiotherapy-naive patients to lesions except for brain; following conditions are exceptionally permitted.
a. Palliative radiotherapy outside of the lung terminated more than 7 days before registration.
b. Post-operative radiotherapy before initial recurrence.
c. Definitive chemo-radiotherapy for initial treatment
d. Stereotactic radiotherapy in early lung cancer (cT1-2N0M0)
9. Patients without uncontrollable effusion
10. Patients who have failed on or relapsed after initial treatment with a combination of immune checkpoint
inhibitors and platinum based chemotherapy or definitive chemo-radiotherapy following durvalumab maintenance therapy.
11. Patients who received only one prior regimen which includes definitive chemo-radiotherapy following durvalumab maintenance therapy.
12. Patients with no prior chemotherapy nor radiotherapy for other malignancies
13. No major surgery within 28 days before registration
14. No minor surgery within 7 days before registration
15. ECOG performance status (PS) of 0-1
16. Life expectancy of 12 weeks or longer
17. Patients who have recovered to grade 1 or less from the toxicity of prior treatment with a combination of immune checkpoint inhibitors and platinum-based chemotherapy
18. No radiation pneumonitis or stable radiation pneumonitis grade 1 or less on registraion if patients received any previous radiotherapy including lung field.
19. Adequate organ function
20. Patients who have no HBs antigen nor antibody to HBV
21. Patients who are willing to abide by contraception

Exclude criteria

Patients are ineligible if any one of following conditions is applicable.
1. Patients with active double cancer
2. Patients receiving continuous systemic administration of steroids (10mg prednisolone equivalent or more) or immunosuppressants
3. Patients with diabetes mellitus requiring insulin injection
4. Patients with uncontrollable thromboembolic disease
5. Patients with clinically important interstitial pneumonitis or pulmonary fibrosis, or history of interstitial pneumonitis on imaging studies
6. Patients who have severe coronary disease, uncontrollable congestive heart failure, or uncontrollable arrhythmia
7. Patients with angina pectoris or myocardial infarction within 6 months before registration
8. Patients with uncontrollable hypertension despite antihypertensive treatment
9. Patients with severe liver cirrhosis
10. Patients with a history of severe hypersensitivity to any study drug
11. Patients with local or systemic active infections that require treatment
12. Patients judged to be difficult to enroll in the study due to clinically problematic psychiatric / neurological disorders
13. Patients who are participating in other clinical trials which are competing against the study
14. Pregnant women, women under breastfeeding, or women who may be currently pregnant
15. History of drug abuse
16. Patients who are judged inappropriate to enroll the study by the doctor in charge

Related Information

• Primary Sponsor: Yoshioka Hiroshige
• Source(s) of Monetary Support: Nippon Kayaku Co., Ltd.