| CTRI Number |
CTRI/2025/03/082809 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Performance Status (General condition) in Advanced Lung cancer with chemotherapy and Immunotherapy |
|
Scientific Title of Study
|
An open label phase-2 randomized-clinical-trial to evaluate the efficacy and safety of low-dose nivolumab and low-dose chemotherapy in patients of advanced NSCLC with poor PS |
| Trial Acronym |
ImPACt-I |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Prabhat Singh Malik |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room no - 245, Department of medical oncology
2nd floor, Dr. B.R. Ambedkar Institute of Rotary Cancer Hospital, AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
09968325318 |
| Fax |
|
| Email |
drprabhatsm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Prabhat Singh Malik |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room no - 245, Department of medical oncology
2nd floor, Dr. B.R. Ambedkar Institute of Rotary Cancer Hospital, AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
09968325318 |
| Fax |
|
| Email |
drprabhatsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Prabhat Singh Malik |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room no - 245, Department of medical oncology
2nd floor, Dr. B.R. Ambedkar Institute of Rotary Cancer Hospital, AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
09968325318 |
| Fax |
|
| Email |
drprabhatsm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRABHAT SINGH MALIK |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Room no 245, Department of Medical Oncology, Dr. B. R. Amdekar Institute of rotary Cancer Hospital, AIIMS, Ansari Nagar
South
DELHI |
09968325318
drprabhatsm@gmail.com |
| DR KUMAR PRABHASH |
Tata Memorial Centre |
Room no. 204, 2nd floor, Homi Bhabha block,
Department of Medical oncology, Dr. E Borges Road, Parel
Mumbai
MAHARASHTRA |
022-24177214
kprabhash1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
low-dose chemotherapy (i.e. Paclitaxel and carboplatin |
low-dose chemotherapy (i.e. paclitaxel 60 mg/m2 IV weekly for first 6 weeks followed by paclitaxel 60 mg/m2 with carboplatin auc 2 |
| Intervention |
Nivolumab 20 mg + Low dose chemotherapy (Paclitaxel and Carboplatin) |
Low-dose nivolumab (20 mg IV every 3 weeks) plus low-dose
chemotherapy (i.e. paclitaxel 60 mg/m2 IV weekly for first 6 weeks followed by paclitaxel 60
mg/m2 with carboplatin AUC 2 at D1, 8, and 15 every 3 weekly in cases where PS improves
to 2 or less) for up to 4 cycles, followed by maintenance with low dose nivolumab monotherapy
until disease progression or unacceptable toxicity. Patients with non-squamous histology and
having non progressive disease after 4 cycles and improved PS will have the option of receiving
pemetrexed maintenance along with low dose nivolumab. Patients who’ll not have any
improvement in PS after initial 6 weeks will have the option of continuing single agent
chemotherapy with low dose nivolumab. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 65 years
2. Histologically or cytologically confirmed NSCLC
3. Stage 4 or stage 3B or 3C as per AJCC 8th edition which is not amenable for curative
intent treatment
4. ECOG performance status of 2 or more
5. Charlson comorbidity score of less than 9 with any comorbidity well under control
6. Measurable disease per RECIST v1.1
7. Adequate organ function:
a. eGFR of greater than 30ml per min,
b. LFT with Bilirubin less than two times ULN and transaminases less than three
times ULN
c. Adequate bone marrow function
i Hb greater than 8gm/dl
ii Platelet greater than 1,00,000 per mm3
iii ANC greater than 1500 per mm3
8. Serum albumin 3.5 gm per dl
9. Written informed consent
|
|
| ExclusionCriteria |
| Details |
1 Active malignancy other than NSCLC currently or in the past 5 years
2 Lactating and pregnant women
3 HIV positive patients, hepatitis B positive patients and HCV positive patients
4 Driver mutation-positive: EGFR, ALK and ROS1
5 Symptomatic, untreated brain metastasis.
6 Asymptomatic incidentally detected brain metastasis and treated brain metastasis will not
be excluded provided not requiring steroids.
7 Prior treatment with an anti–PD-1, anti–PD-L1, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
8 Active, known, or suspected autoimmune disease (except type I diabetes mellitus, hypothyroidism, skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment, and conditions not expected to recur in the absence of an external trigger)
9 Use of corticosteroids (10 mg daily of prednisone equivalent) or other immunosuppressive medications within 14 days of treatment assignment
10 Evidence of interstitial lung disease which is symptomatic and whose clinical presentation/management may interfere with the detection and/or treatment of pulmonary toxicity due to immunotherapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 6-month progression-free survival (PFS) rate |
6 month after randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall response rate (ORR), overall survival (OS), quality of life (QoL), toxicities as per CTCAE v 5 |
At Week-0 & 6, 03 months, 06 months during the entire study period |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drprabhatsm@gmail.com].
- For how long will this data be available start date provided 01-01-2029 and end date provided 01-01-2034?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An ECOG performance status of greater than 2 is seen in 30-50 percent of advanced NSCLC patients. This can be due to high disease burden, comorbidities, age or impaired nutrition. Therapeutic options for these patients are limited. Immune checkpoint inhibitors (ICIs) have limited efficacy in these patients. Moreover, the cost of ICIs is prohibitive for most patients in India. There is need to develop innovative and cost effective treatment strategies for this difficult to treat patient populations. We propose a study testing the feasibility of incorporating LdICI with low dose chemotherapy in carefully selected patients with poor PS. This would be the first study of LdIO plus CT in carefully selected, advanced NSCLC patients with poor PS using an adaptive, economically viable approach. The primary objective of the study is to see improvement in 6 month PFS (progression free survival) rate and the secondary objectives are response rates, overall survival, change in quality of life, and corelation of response with PDL1 expression This will be an Open-label phase-II randomised-control-trial. Patients with driver-mutation negative advanced NSCLC patients with poor PS will be enrolled. The intervention arm will receive : Nivolumab 20 mg every 21days (LdICI), plus weekly paclitaxel for 4-6 weeks. Contingent on improvement in ECOG PS by 1 point and score less than 2, carboplatin will be added to remaining three cycles, followed by maintenance. The comparator arm will receive the same chemotherapy regimen without nivolumab. This study will test the feasibility of a new approach in this difficult to treat patient population, and if successful, will be able to provide a safe, efficacious and economically feasible option for their management. |