tility of blood based DNA analysis for treatment modification in lung cancer.

Not Applicable

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

• Registration Number: CTRI/2022/05/042555
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age 18- 65yrs

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

3.Treatment naïve plasma EGFR mutant positive NSCLC for exon 19, 21 or 18 (adenocarcinoma/not otherwise specified)

4.Being considered for EGFR TKI as first line treatment

5.Stage IV and IIIB or C non squamous NSCLC not amenable to radical radiotherapy/ chemoradiation

6. Adequate organ function, including the following:

i) Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) >= 1.5X109 /L, Platelets >=100X109 /L

ii) Hepatic: bilirubin <= 1.5 times the upper limit of normal(xULN), Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <= 3.0 times the ULN if no demonstrable liver metastases (AST, ALT <= 5 XULN is acceptable if liver has tumor involvement). Serum Creatinine <= 1.5 times the ULN or Creatinine Clearance >= 60 ml/min.

7.No h/o ILD at baseline

8.Willingness to comply with all study requirements, including treatment, timing and/or nature of required assessments

Exclusion Criteria

1.Poor PS (3 or 4)

2.Pre-existing Interstitial lung disease documented by CT at baseline

3.Symptomatic brain metastasis (treated, asymptomatic brain metastasis would be allowed)

4.Pregnant and lactating women

5.Not able to take oral medicines

6.History or presence of any other malignancy

7.Past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.

8. Life expectancy of <= 12 weeks

9. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate 6-month Progression free survival (PFS) rate by adding chemotherapy to gefitinib in patients with residual CtDNA after 9 weeks to 11 weeks of gefitinib monotherapyTimepoint: To evaluate 6-month Progression free survival (PFS) rate by adding chemotherapy to gefitinib in patients with residual CtDNA after 9 weeks to 11 weeks of gefitinib monotherapy

Secondary Outcome Measures

Name	Time	Method
1. To assess PFS in patients on gefitinib monotherapy who clears CtDNA at 9 to 12 weeks <br/ ><br>2. To assess the time to clear CtDNA after adding chemotherapy to gefitinib <br/ ><br>3. To assess the time to emergence of secondary resistance mutation(T790M) by CtDNA <br/ ><br>5. Correlation of emergence of T790M mutation by liquid biopsy with radiological/clinical progression <br/ ><br>4. Toxicity profile in patients on gefitinib and chemotherapy <br/ ><br>5. To assess quality of life after the addition of chemotherapy to gefitinib using EORTC QLQ -C30 and LC13 questionnaire <br/ ><br>Timepoint: 1. 6 -month PFS in patients on Gefitinib monotherapy who have cleared CtDNA at 9 weeks to 11 of gefitinib monotherapy <br/ ><br> <br/ ><br>2.CtDNA clearance at the end of 3 months of adding chemotherapy to gefitinib <br/ ><br>5.Safety evaluation every 4 weeks <br/ ><br>6.Quality of life assessment at baseline, before adding chemotherapy and then every 3 months. <br/ ><br>