Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Intervention in standard arm ( Arm A): In participants diagnosed with Squamous Cell Carcinoma - Paclitaxel ( 175 mg/m2) with Platinum ( Cisplatin- 75 mg/m2 or Carboplatin AUC -5) every
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival.Timepoint: At the End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression free survival 2.overall response rate 3.To assess & compare the safety & tolerability 4.Quality of lifeTimepoint: 1. At every 3 to 4 cycles 2. At every 3 to 4 cycles 3. At every cycle 4. At baseline & every 2 months | — |
Countries
India
Contacts
Public ContactDr Nandini Menon
Tata Memorial Hospital
Outcome results
None listed