Carboplatin & Paclitaxel (CP)

CP: Carboplatin & Paclitaxel

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Forde et al. 2022 (CheckMate 816)	2017-2019	Phase 3 (C)	1a. CP & Nivolumab 1b. CVb & Nivolumab 1c. DC & Nivolumab	Inferior EFS

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.

Biomarker eligibility criteria

CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

Carboplatin (Paraplatin) AUC 5 or 6 IV once on day 1
Paclitaxel (Taxol) 175 or 200 mg/m² IV once on day 1

21-day cycle for 3 cycles

Subsequent treatment

Complete resection

References

CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02998528

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Note: these eligibility criteria, which pertain mainly to treatment regimens, are guidelines; they are not hard-and-fast. For example, if a contributor or a member of our Editorial Board requests that a certain regimen be added, we will strive to do this even if the criteria are not strictly met. See the content tutorial and sources pages for more information. As outlined in our disclaimer, inclusion of a regimen on HemOnc.org is not an endorsement of its efficacy or appropriateness for use in any given clinical situation.

Non-randomized or retrospective studies

Regimens consisting solely of approved drugs

There is no strict cutoff for efficacy
The regimen should be described by the authors as equivalent or better than standard-of-care, using such terms as "promising", "new standard-of-care", "at least as good", etc.
If comparative efficacy to historic controls is reported, the new regimen should have a statistically superior outcome, defined as p-value less than or equal to 0.10 (see levels of evidence)
The study should have at least 20 participants

Regimens that include an experimental drug

The study should meet its predetermined primary efficacy endpoint
It should be clear that the regimen will go on to be tested in phase III trials
- Exception: if the regimen is the basis of an FDA approval, this is not required
With few exceptions, the study should have at least 20 participants
- If a phase I or Ib study, this should be at least 20 participants receiving the MTD

Randomized trials

Control arm(s)

These will generally always be added to HemOnc.org, if they are missing

Experimental arm(s)

These will be added if the experimental arm has a statistically superior primary outcome, defined as p-value less than or equal to 0.10 (see levels of evidence)
These will be generally not be added if the experimental arm has a statistically nonsignificant primary outcome, defined as p-value greater than 0.10 (see levels of evidence)
- Exception: if the secondary outcome is the basis of an FDA approval, we will add the regimen

Prioritization

Because HemOnc.org is a voluntary effort driven by the contributors, it is not possible to add every treatment regimen, in anything close to real time. What follows is a general prioritization list for adding new regimens to the more heavily studied disease pages. In some diseases, there is no randomized literature so this prioritization does not apply:

New treatment regimens, evaluated in phase III RCTs, published in top-tier journals (NEJM, Lancet, JCO, Blood, Lancet Oncology, JAMA Oncology)
1. Control arms of RCTs cited by the paper describing these regimens
2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
New treatment regimens, evaluated in phase III RCTs, published in other journals (see Sources)
1. Control arms of RCTs cited by the paper describing these regimens
2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
New treatment regimens, evaluated in phase III RCTs, published in conference proceedings (see Sources)
New treatment regimens, evaluated in randomized phase II RCTs, published in top-tier journals (NEJM, Lancet, JCO, Blood, Lancet Oncology, JAMA Oncology)
1. Control arms of RCTs cited by the paper describing these regimens
2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
New treatment regimens, evaluated in randomized phase II RCTs, published in other journals (see Sources)
New treatment regimens, evaluated in non-randomized trials, published in top-tier journals (NEJM, Lancet, JCO, Blood, Lancet Oncology, JAMA Oncology)
1. Control arms of RCTs cited by the paper describing these regimens
2. Experimental arms of RCTs cited by the paper describing these regimens, if they have statistically superior findings
New treatment regimens, evaluated in non-randomized trials, published in other journals (see Sources)
Old treatment regimens evaluated in RCTs, identified by other means not described above
Old treatment regimens evaluated in non-randomized trials, identified by other means not described above

Eligibility criteria

Contents