NIPH Clinical Trials Search

JRCT ID: jRCTs051200138

Registered date:17/02/2021

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.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNon-small-cell lung cancer
Date of first enrollment25/02/2021
Target sample size45
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeObjective response rate: ORR
Secondary OutcomeOverall 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 maximumNot applicable
Include criteriaAll 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 criteriaPatients 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


Public contact
Name Hiroshige Yoshioka
Address 3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan Osaka Japan 573-1191
Telephone +81-72-804-0101
Affiliation Kansai Medical University Hospital
Scientific contact
Name Hiroshige Yoshioka
Address 3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan Osaka Japan 573-1191
Telephone +81-72-804-0101
Affiliation Kansai Medical University Hospital