A study to evaluate immunotherapy pembrolizumab with chemotherapy in lung cancer patient.

Phase 3

Recruiting

Conditions: Malignant neoplasm of lower respiratory tract, part unspecified,

Registration Number: CTRI/2023/08/056715

Lead Sponsor: Tata Memorial Hospital

Brief Summary: ScreeningPatients will be screened post-consenting. Each referred patient will be assessed on the basis of study eligibility criteria for this study. Investigations mentioned under baseline assessment would be performed at the time of screening if necessary for eligibility assessment.

Safety assessment and other assessments at baseline Subjects will undergo the following assessment at baseline, within 15 days of the screening visit:

1. History and physical examination

2. Documentation of ECOG PS

3. Blood investigations

1. Complete blood hemogram

2. Renal function test (RFT) inclusive of serum urea and serum creatinine

3. Liver function test (LFT) inclusive of serum SGOT, SGPT, total bilirubin and alkaline phosphatase

4. Serum serology (HIV, HBsAg and HCV). HCV RNA testing will be performed if anti-HCV antibody screening test is positive.

5. Free Serum T4 and TSH

6. Urine pregnancy test (or any other suitable alternative test like serum beta HCG ) for women of childbearing potential

7. urine routine microscopy

4. Axial imaging of the lesion

5. European Organisation for Research and Treatment of Cancer Questionnaires (EORTC) QLQ-C 30 and EORTC QLQ -LC13 module will be self administered

6. Biopsy with 10 ml blood (5 ml EDTA and 5ml Plain) will be collected at baseline and also 2-3 months interval for future laboratory work.

Number of cycles4-6 cycles. Further maintenance therapy can be planned as per institutional standards at the discretion of treating physician.

Sample sizeWith the assumption of1.5 year survival of 25% in chemotherapy arm, we expect the expected survival of 35% in chemotherapy and immunotherapy arm. With alpha of 0.05 percent and power of 80% we will require 342 patients. We expect dropout of 10%. We will require 380 patients for this study.

Sequence generationStratified randomisation with block size of 4 will be performed. The following stratification factors will be accounted

Site (Squamous versus Non-Squamous)

Agent (Cisplatin versus carboplatin)

ECOG PS (0-1 versus 2)

Brain metastasis (present versus absent)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 380

Inclusion Criteria

Subjects must have NSCLC, for adenocarcinoma EGFR, ALK negative mutated and must have been planned for palliative systemic therapy 2.
Age: Male or female subjects aged â‰¥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
Subjects must have normal organ and marrow function 5.
Both men and women of all races and ethnic groups are eligible for this study.
Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Subjects who are receiving any other current investigational agents.
IMMUNOSUPPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a.
intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b.
Systemic corticosteroids at physiologic doses â‰¤ 10 mg/day of prednisone or equivalent; c.
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d.
Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis.
AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent.
Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
ORGAN TRANSPLANTATION: Prior organ transplantation including allogeneic stem-cell transplantation.
INFECTIONS: Active infection requiring systemic therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival.	At the End of study

Secondary Outcome Measures

Name	Time	Method
1.Progression free survival	2.overall response rate

Trial Locations

Locations (6): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
🇮🇳
Jaipur, RAJASTHAN, India
HOMI BHABHA CANCER HOSPITAL& RESEARCH CENTRE NEW CHANDIGARH, PUNJAB
🇮🇳
Chandigarh, CHANDIGARH, India
Mahatma Pandit Madan Mohan Malaviya Cancer Centre & Homi Bhabha Cancer Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Oncowin Cancer Center
🇮🇳
Ahmadabad, GUJARAT, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Aparna Sharma
Principal investigator
7895683095
aparna96@gmail.com