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Anti-tumor antibiotic

Carboplatin + Taxane + Ramucirumab for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Melina Marmarelis, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two

PS 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose of study drug until death, last observation or contact, an average of 1-2 years

Awards & highlights

Study Summary

This trial will study if combining three cancer drugs helps shrink tumors or delays tumor growth in patients with non-small cell lung cancer. It will also assess if it is safe to combine these drugs.

Who is the study for?

Adults with advanced non-squamous NSCLC (Stage IV or recurrent) who have had 4-6 cycles of Pem/Carbo/Pembro and disease progression after at least 18 weeks on maintenance Pemetrexed, Pembrolizumab, or both. Participants must be in good physical condition (PS 0-1). Not eligible if they have treatable mutations, other cancers needing treatment, moderate to severe sensory neuropathy, untreated brain metastases, or a history of significant bleeding.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of combining three drugs: Carboplatin, Paclitaxel, and Ramucirumab for patients with NSCLC who've previously been treated with Pemetrexed or Pembrolizumab. The goal is to see if this drug combo can shrink tumors or slow their growth.See study design

What are the potential side effects?

Possible side effects include reactions related to infusion such as fever and chills; blood-related issues like anemia; nerve damage that could cause tingling sensations; increased risk of infections; fatigue; digestive problems like nausea and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had 4-6 cycles of Pem/Carbo/Pembro and my condition worsened after 18 weeks on maintenance therapy.

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I am fully active or can carry out light work.

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I am 18 or older with advanced non-squamous NSCLC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of study drug until death, last observation or contact, an average of 1-2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first dose of study drug until death, last observation or contact, an average of 1-2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug until death, last observation or contact, an average of 1-2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To estimate overall response rate

Secondary outcome measures

Overall Survival

Progression-free survival

Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100

60%

ALOPECIA

51%

NAUSEA

45%

ARTHRALGIA

44%

ANAEMIA

38%

FATIGUE

35%

HYPERTENSION

35%

CONSTIPATION

35%

DIARRHOEA

30%

NEUTROPENIA

28%

PERIPHERAL SENSORY NEUROPATHY

28%

ABDOMINAL PAIN

28%

NEUTROPHIL COUNT DECREASED

24%

NEUROPATHY PERIPHERAL

24%

RASH

23%

HEADACHE

23%

VOMITING

22%

WHITE BLOOD CELL COUNT DECREASED

22%

MYALGIA

21%

PLATELET COUNT DECREASED

21%

PROTEINURIA

21%

EPISTAXIS

21%

THROMBOCYTOPENIA

19%

DECREASED APPETITE

18%

HYPOTHYROIDISM

17%

URINARY TRACT INFECTION

16%

COUGH

16%

PYREXIA

15%

STOMATITIS

14%

HYPOMAGNESAEMIA

14%

ASPARTATE AMINOTRANSFERASE INCREASED

14%

BACK PAIN

14%

INSOMNIA

14%

ALANINE AMINOTRANSFERASE INCREASED

14%

DYSPNOEA

14%

PRURITUS

13%

WEIGHT DECREASED

13%

PAIN IN EXTREMITY

12%

DIZZINESS

12%

INFUSION RELATED REACTION

12%

ASTHENIA

11%

LEUKOPENIA

11%

HYPOKALAEMIA

10%

UPPER RESPIRATORY TRACT INFECTION

DYSGEUSIA

ABDOMINAL PAIN UPPER

FEBRILE NEUTROPENIA

HYPOAESTHESIA

WEIGHT INCREASED

HYPERTHYROIDISM

DYSPHONIA

BONE PAIN

LYMPHOCYTE COUNT DECREASED

MUCOSAL INFLAMMATION

MUSCULAR WEAKNESS

HYPONATRAEMIA

PARAESTHESIA

OROPHARYNGEAL PAIN

DYSPEPSIA

RASH MACULO-PAPULAR

HYPERGLYCAEMIA

BLOOD ALKALINE PHOSPHATASE INCREASED

OEDEMA PERIPHERAL

NASOPHARYNGITIS

ABDOMINAL DISTENSION

ANXIETY

PAIN

DEPRESSION

DRY MOUTH

MALAISE

NASAL CONGESTION

VISION BLURRED

DRY SKIN

URTICARIA

HOT FLUSH

NECK PAIN

GASTROOESOPHAGEAL REFLUX DISEASE

ILEUS

PNEUMONIA

PULMONARY EMBOLISM

COLITIS

SMALL INTESTINAL OBSTRUCTION

INTESTINAL OBSTRUCTION

PERITONITIS

LIVER INJURY

UROSEPSIS

DEHYDRATION

TRANSIENT ISCHAEMIC ATTACK

PNEUMONITIS

ABDOMINAL ABSCESS

INFECTED LYMPHOCELE

PYELONEPHRITIS

100%

80%

60%

40%

20%

Study treatment Arm

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Placebo With Paclitaxel, Carboplatin and Bevacizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Carboplatin, Taxane And RamucirumabExperimental Treatment3 Interventions

Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Ramucirumab

2017

Completed Phase 3

~5050

Paclitaxel

2011

Completed Phase 4

~5380

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,585 Total Patients Enrolled

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

104,985 Total Patients Enrolled

Melina Marmarelis, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

Media Library

Carboplatin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04332367 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Carboplatin, Taxane And Ramucirumab

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04332367 — Phase 2

Carboplatin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332367 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which ailments is Carboplatin commonly prescribed?

"Carboplatin is a useful treatment for malignancies such as advanced endometrial cancer, melanoma, and the metastasis of neoplasms."

Answered by AI

Are enrollment opportunities for this clinical research still available?

"The clinical trial is presently enlisting suitable candidates. According to the data on clinicialtrials.gov, it was first posted in December of 2019 and last revised in March 2022."

Answered by AI

To what extent is this research currently being administered to participants?

"Affirmative. Per the information on clinicaltrials.gov, this investigation is actively looking for participants; it was initially publicized on December 19th 2019 and last modified on March 14th 2022. As of now, 59 people need to be recruited from 1 particular site."

Answered by AI

Could you provide details about other investigations that have been conducted using Carboplatin?

"Presently, there are 1202 studies ongoing pertaining to Carboplatin. 336 of those research projects are in their terminal phase (Phase 3). Although most trials for this drug occur in Shanghai, 68231 locations around the globe have clinical trial sites."

Answered by AI