A study to compare Nanosomal Docetaxel Lipid Suspension with Docetaxel as a second line therapy lung cancer patients

Randomised Control Trial Comparing Nanosomal Docetaxel Lipid Suspension (Ndls) Vs Docetaxel As Second Line Therapy In Palliative Sitting Of Non Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025302

Enrollment

446

Registered

2020-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Docetaxel: Patients on Docetaxel 75mg/m2 every three weekly until progressive disease/intolerable side effects Docetaxel will be administered Intravenously Control Intervention1: Nanoso

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients aged 18 years or older 2.Diagnosed Non small cell lung cancer patients- Histological or cytologically provenwith mutation negativeor mutation unknown who are planned with the treatment with palliative intent. 3.Patients progressed during or after first line chemotherapy or disease progression within 6 months of treatment after curative treatment where chemotherapy has been administered. 4.Adequaterenal,cardiac and marrow function defined as Creatinine creatinineclearance >=45ml/min AST,ALT2,5mg/dl Left ventricular ejection fraction >= lower limit of normal by ECHO Haemoglobin >=8mg/dl, Absolute neutrophil count >=1200/mm3,Platelets>=1,00,000/mm3 5.ECOG performance status 0-2 6.Patients must be willing to complete EORTC QOL 7.Patient willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.History or presence of any other malignancy with exception of basal cell carcinoma or cervical cancer insitu. 2.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. 3.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease). 4. Known HIV infection, active hepatitis B or C infection. 5.Unwillingness to comply with study procedures 6.Pregnant and breast feeding ladies

Design outcomes

Primary

Measure	Time frame
To compare overall survival of Nanosomaldocetaxel lipidsuspension(NDLS) vsDocetaxel in metastatic NSLCTimepoint: Till Death	—

Secondary

Measure	Time frame
To compare NDLS with Docetaxel in terms of 1. Response rate (RR)with RECIST criteria (1.1) 2. Progression free survival(PFS) 3. Quality of life(QOL) with EORTC QLQ, C - 30, LC-13 4. Toxicity with CTCAE( common toxicity criteria for adverse events)-version 4.03 5. Toxicity due to docetaxel-infusion related toxicities, alcohol additives related toxicities. 6. Brain Metastasis PFS Timepoint: 1. Response rate every 2 to 3 months 2. PFS: Till progression of disease 3. QOL: At each visit 4. toxicity: at each visit	—

Measure

Time frame

To compare NDLS with Docetaxel in terms of 1. Response rate (RR)with RECIST criteria (1.1) 2. Progression free survival(PFS) 3. Quality of life(QOL) with EORTC QLQ, C - 30, LC-13 4. Toxicity with CTCAE( common toxicity criteria for adverse events)-version 4.03 5. Toxicity due to docetaxel-infusion related toxicities, alcohol additives related toxicities. 6. Brain Metastasis PFS Timepoint: 1. Response rate every 2 to 3 months 2. PFS: Till progression of disease 3. QOL: At each visit 4. toxicity: at each visit

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Countries

India

Contacts

Public ContactDr Kumar Prabhash

Tata Memorial Hospital

kprabhash1@gmail.com9167760576

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026