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

Phase 3

Conditions: Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified

Registration Number: CTRI/2023/08/056715

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. 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 = 18 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.

4. Subjects must have normal organ and marrow function

5. Both men and women of all races and ethnic groups are eligible for this study.

6. 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.

7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Subjects who are receiving any other current investigational agents.

2. 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 = 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.

3. 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.

4. ORGAN TRANSPLANTATION: Prior organ transplantation including allogeneic stem-cell transplantation.

5. INFECTIONS: Active infection requiring systemic therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival.Timepoint: At the End of study

Secondary Outcome Measures

Name	Time	Method
1.Progression free survival <br/ ><br>2.overall response rate <br/ ><br>3.To assess & compare the safety & tolerability <br/ ><br>4.Quality of lifeTimepoint: 1. At every 3 to 4 cycles <br/ ><br>2. At every 3 to 4 cycles <br/ ><br>3. At every cycle <br/ ><br>4. At baseline & every 2 months