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Alkylating agents

Nab-paclitaxel for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Nisha Mohindra, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up begin c1d1 and every 2 cycles (6 weeks) thereafter, for up to 2 years or until unacceptable toxicity.
Awards & highlights

Study Summary

This trial is a phase I/II study for previously untreated subjects with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~begin c1d1 and every 2 cycles (6 weeks) thereafter, for up to 2 years or until unacceptable toxicity.
This trial's timeline: 3 weeks for screening, Varies for treatment, and begin c1d1 and every 2 cycles (6 weeks) thereafter, for up to 2 years or until unacceptable toxicity. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Recommended Phase II Dose
Phase II: Disease Assessment for Progression-Free Survival (PFS)
Phase II: Objective Response Rate
Secondary outcome measures
All Phases: Assessment of Association of PD-L1 Expression on PFS
Phase I : Objective Response Rate
Phase I: Disease Assessment for Anti-Tumor Activity
+5 more

Side effects data

From 2016 Phase 3 trial • 50 Patients • NCT02019277
70%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Psychotic disorder
2%
Syncope
2%
Dermatitis bullous
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Phase II Investigational TreatmentExperimental Treatment3 Interventions
Subjects will be treated with carboplatin AUC 6 given IV on Day 1, nab-paclitaxel 100 mg/m^2 given IV on Day 1, Day 8, and Day 15, and pembrolizumab 200mg IV on Day 1 of each cycle. Pembrolizumab Phase II treatment will continue for a maximum duration of 4 cycles (cycle = 21 days). Maintenance Therapy For participants who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with MK-3475 2* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from C1D1. *As additional data from ongoing trials becomes available, the dose of MK-3475 may be adjusted.
Group II: Arm A: Phase I Dose Finding CohortExperimental Treatment3 Interventions
Twelve subjects will be enrolled and treated with carboplatin AUC 6 IV on Day 1, nab-paclitaxel 100 mg/m^2 IV on Day 1, Day 8, and Day 15, pembrolizumab 2* mg/kg IV on Day 1 for 4 cycles. pembrolizumab (Phase I) treatment for Cohort 1 will continue for a maximum duration of 4 21-day cycles Phase I, Cohort 1 Maintenance Therapy: Participants who have confirmed CR, PR, or SD (non-progression) after 4 cycles, maintenance therapy with MK-3475 2* mg/kg will continue on D1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or a maximum of 2 years from C1D1. If unacceptable toxicity is seen in Phase I Cohort 1, 12 additional participants will be enrolled in Cohort 2 and treated with carboplatin AUC 6 IV on D1, nab-paclitaxel 100 mg/m2 IV on D1, D8, and D15, MK-3475 2*mg/kg IV on D1 starting C2. MK-3475 (Phase 1) treatment for Cohort 2 will continue for a maximum duration of 3 21-day cycles (C2-4 only).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

Nisha Mohindra, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,255 Total Patients Enrolled
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,709 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC
Nisha Mohindra, MD 2015. "Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02382406.
~5 spots leftby Apr 2025
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