Improving Performance status of Advanced lung cancer patients with Chemotherapy

Phase 2

Conditions: Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Registration Number: CTRI/2020/01/022617

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Cytologically/pathologically confirmed NSCLC either stage 4 disease or those stage IIIC not amenable to definitive chemoradiation. (AJCC 8th)

2.ECOG Performance status more than or equal to 2 ECOG with:

i.Charlson comorbidity index of less than 9

ii.Comorbidities, if any, should be controlled.

iii.Serum albumin more than or equal to 3.5g/dl

iv. Acceptable renal and liver function,

v.eGFR of more than or equal to 30ml/min,

vi.LFT with Bilirubin less than 2 times ULN and transaminases less than 3 times ULN

vii.Adequate bone marrow function:Hb of more than or equal to 8g/dl,Platelet count of more than or equal to 1,00,000/mm3,ANC of more than or equal to 1500/mm3

3.Able to understand the PIS (patient information sheet) and give informed consent

Exclusion Criteria

1.Active malignancy other than NSCLC

2.Lactating and pregnant woman

3.HIV positive patients

4.Driver mutation positive: EGFR/ALK/ROS1

(Patients who have unknown or awaited status of these driver mutations will be eligible, however, if during the study, they are found to harbour these mutations, they will be out of the study.)

5.Symptomatic untreated brain metastasis.

(Asymptomatic incidentally detected brain metastasis and treated brain metastasis will not be excluded.)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with improvement in ECOG performance status score by at least one point.Timepoint: At four weeks from start of treatment.

Secondary Outcome Measures

Name	Time	Method
For part 2 of study: <br/ ><br>Overall Response rate (ORR) at 12 weeks <br/ ><br>Progression free survival (PFS) rate at 6 monthsTimepoint: ORR at 12 weeks <br/ ><br>PFS rate at 6 months;Quality of life with LC13 and EORTC QLQ C30Timepoint: 0 weeks,4 weeks, and for selected patients, at 12 weeks.